KEMENTERIAN KESEHATAN REPUBLIK INDONESIA

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KEMENTERIAN KESEHATAN REPUBLIK INDONESIA

DIREKTORAT JENDERAL KEFARMASIAN DAN ALAT KESEHATAN

Jalan H.R. Rasuna Said Blok X-5 Kavling 4 - 9 Jakarta 12950 Telepon : (021) 5201590 Pesawat 2029, 8011

Faksimile : (021) 52964838 Kotak Pos : 203

Catatan:

- UU ITE No 11 Tahun 2007 Pasal 5 ayat 1

Informasi Elektronik dan/atau Dokumen Elektronik dan/atau hasil cetaknya merupakan alat bukti hukum yang sah. - Dokumen ini telah ditandatangani secara elektronik menggunakan sertifikat elektronik yang diterbitkan BSrE.

Berdasarkan Peraturan Menteri Kesehatan R.I Nomor 62 Tahun 2017 Tentang Izin Edar Alat Kesehatan, Alat Kesehatan Diagnostik In Vitro Dan Perbekalan Kesehatan Rumah Tangga dengan ini diberikan persetujuan untuk diedarkan dengan :

NOMOR IZIN EDAR

A L A T K E S E H A T A N

KEMENKES RI AKL 21501814503

Nama Dagang / Merek : CANON CT Scanner Aquilion Prime SP

Kelompok / Kelas Resiko : Elektromedik Radiasi / C

Kategori Produk : Peralatan Radiologi

Sub Kategori : Peralatan Radiologi Diagnostik

Jenis Produk : Computed tomography x-ray system.

Tipe / Ukuran : Model TSX-303B

Kemasan : Unit

Nama Produsen / Pabrikan : CANON MEDICAL SYSTEMS CORPORATION, Japan

Nama Pendaftar : PT. MURTI INDAH SENTOSA, DKI Jakarta

Atas dasar lisensi dari :

-Ketentuan

1. Persetujuan izin edar berlaku sampai dengan 31 Desember 2024.

2. Wajib menyampaikan laporan berkala dan laporan jika ada kejadian yang tidak diinginkan akibat

penggunaan Alat Kesehatan tersebut di atas sesuai ketentuan berlaku.

3. Izin edar ini merupakan persetujuan perpanjangan dari Nomor Izin Edar Alat Kesehatan

KEMENKES RI AKL 21501814503 tanggal 11 Juli 2018. Dengan demikian izin edar sebelumnya dinyatakan tidak berlaku.

4. Apabila dikemudian hari ada pihak lain yang berhak atas merek dan/atau keagenan produk

tersebut, pendaftar bersedia mengembalikan izin edar.

5. Penandaan dan informasi produk yang terlampir merupakan bagian yang tidak terpisahkan dari

persetujuan izin edar ini.

6. Apabila di kemudian hari terdapat kekeliruan, maka persetujuan izin edar ini akan ditinjau

kembali.

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KEMENTERIAN KESEHATAN REPUBLIK INDONESIA

Catatan:

LAMPIRAN

_{NOMOR IZIN EDAR}

ALAT KESEHATAN

No. Deskripsi Tipe / Kode

1 Display console kit CGS-72A

2 Double slice kit CSDS-002A

3 X-ray high voltage gnerator CXGS-011A

4 4D airways analysis CSAA-001A

5 4D cerebral artery morphological analysis CSAM-001A

6 Body organ perfusion CSBP-002A

7 Body organ perfusion CSBP-004A

8 Cardiac function alaysis software (CFA) CSCF-002A

9 Cerebral blood-flow analysis system (CBP-study) CSCP-002A

10 Colon view CSCV-001A

11 Display system for dental application CDP-07A

12 Dual energy system CSDE-001A

13 Dual energy comporition analysis CSDC-001A

14 Dynamic shuttle body perfusion CSDB-001A

15 Fat index view CSFM-001A

16 FlytThrough software CFT-03A

17 Lung volume analysis CSLV-001A

18 Shuttle helical brain perfusion CSSB-001A

19 Sure Cardio scoring CSCS-001A

20 Sure Plague CSPV-002A

21 Sure Subtraction scan system CHSS-001A

22 Sure Subtraction angio CSSA-001A

23 Sure Subtraction iodine mapping CSSI-001A

24 Sure Subtraction lung CSSL-001A

25 Sure Subtraction ortho CSSO-001A

26 Vessel view CW-001A

27 Wide volume brain perfusion CSWB-001A

28 ECG-gated scan system CHEG-005A

29 Extended field of view CSTC-005A

30 Injector synchronization system, CAN protocol class-1 CKIS-004B

31 Orbital synchronized scan system CKOS-001A

32 Respiratory-gated scan system CKRS-004A

33 Respiratory-gating system CKRS-004B

34 Shuttle helical scan system CHSH-001A

35 vHP, Variable helical pitch CHVH-001A

36 Color printer interface (PS format) CCP-003A

37 DICOM MPPS COT-33D

38 DICOM MWM COT-32D

39 DICOM PGP profile COT-44A

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KEMENTERIAN KESEHATAN REPUBLIK INDONESIA

Catatan:

No. Deskripsi Tipe / Kode

40 DICOM Q/R SCP COT-34D

41 DICOM Q/R SCU COT-35D

42 DICOM storage commitment SCU COT-41D

43 DICOM storage SCP COT-30D

44 Additional connection kit for raw data storage system COT-52D

45 Fast image recontruction kit CCFR-010A

46 HANDY Snap CAXS-001A

47 Rear operating panel kit CAGP-002A

48 Sure Fluoro TSXF-003I

49 Diagnostic image display unit CMM-004B

50 Sure Xtension COT-49D

51 Couch lateral movement unit CALU-001A

52 Couch lateral movement unit CALU-001B

53 Flat couch top kit CAFT-021A

54 Flat couch top kit CAFT-022A

55 Kit for widening the gap between the gantry and patient couch CAZZ-003A

56 Reart footswitches CAFS-007A

Dengan ketentuan bahwa izin edar tersebut hanya berlaku untuk deskripsi dan tipe / kode produk yang tercantum dalam lampiran ini

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Lampiran 2 dari 2 Halaman Jakarta, 15 April 2020

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canon

Agen Tunggal Alamat : : JI. Sultan lskandar Muda Kav. 29, Kebayoran Lama, PT. MURTI INDAH SENTOSA Distributor Jakarta 12240

Nama Pabrik : CANON MEDICAL SYSTEMS CORPORATION, Japan Nama Produk : CANON CT-ScannerAquilion Prime SP

Alamat Pabrik : 138S Shimoishigami, Otawara-shi, Tochigi, 324-85SO JAPAN

Kemenkes RI : AKL ... ... JAKARTA-INDONESIA

- ~

I

Complete Clinical Capability

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1. SPESIFICA TIONS Scan parameters • Gantry aperture • Rotation • Tilt • Rotation time • Scan field

- CT Scan

• Slice thickness Helical scan

• Continuous scan time

CANON MEDICAL SYSTEM AQUILION PRIME SP

: 780 mm in diameter

: 360° continuous

: ± 30°

:0.35, 0.375,0.4,0.45,0.5,0.6,0.75, 1, 1.5,2,3.s

: 320mm, dan500mm

: 0.5, 1, 2, 3, 4, 5, 8mm

: max 100 s

• Scan field in the longitudinal direction : 1750 mm(with headrest)

• Image reconstruction time

Dynamic scan

• Programmable time

• Real time reconstruction time

suREStart™

• Scan Start Mode

• Continuous scan time

• Region of interest (ROI)

• Display function

time

Patient Couch

• Vertical movement

-

System

: up to 50 images/s

: max 1 hour / exam plan

: 12 images /s

: Manual and Automatic

: max 100 s

: max4ROI

: mean CT number within the ROI and elapsed

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-

Stroke

- Minimum couch-top height

- Maximum couch-top height

• Couch top movement

-

System

-

Stroke

• Couch - top width

: approx. 5 54 mm

: approx. 336 mm

: approx. 900 mm

: motor driven or manual

: 2190 mm (for the long patient couch version)

: 470 mm

• Remote control from the console is possible

• Load limit

: 220 kg

X- Ray Generation

• X- ray exposure

• X-ray tube voltage

• X-ray tube current

• X-ray tube heat capacity

• X-ray tube cooling rate

• Focal spot size

X-Ray Detection

• Detection system

• Main detector

• Data acquisition

Data Processing

• Reconstruction matrix

• Dose reduction function

: Continuos

: 80, 100, 120, and 135 kV

: 10 mA to 500 mA (option 600 mA)

: 7.5MHU

: max 13 86kHU/min

: 0.9 mm x 0.8 mm (small)

1.6 mm x 1.4 mm (large)

: Solid- state detectors

: 896 channels x 80 elements

: 896 channels x 80 rows

: 552

X

1750

- Adaptive Iterative Dose Reduction (AIDR 3D)

- AIDR 3D Enhanced

• Metal artifact reduction function

- Single Energy Metal Artifact Reduction (SEMAR)

• Data Processing unit

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- Memory size

- Magnetic disk unit

or more

Image Display

• Display monitor

• Monitor matrix

Power requirements

• Phase

• Line capacity

: 32 GB or more

: raw data 550 GB or more ; image data 365 GB

: 48 .1 cm (19 inch color) LCD unit

: 1280

X

1024

: three-phase

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cauou

CT SCANNER AQ.Jilion Prime SP

MODEL TSX-3038

INPUT 3/\J380/400/415/440/460/480V 50/60Hz MAX.INPUT POWER 110kVA

SUP.SYMBOL /1C

[SN] **********

• ..J CANON MEDICAL SYSTEMS CORPORATION

- 1385.SHIMOISHIGAMl,OTAWARA-SHl,TOCHGI 324-11550,JAPAN CANON MEDICAL SYSTEMS CORPORATION

4X7o-o8759'A MADE IN JAPAN

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KEMENTERIAN KESEHATAN REPUBLIK INDONESIA

Catatan:

NOMOR IZIN EDAR

Nama Dagang / Merek : VITAL VITREA

Kelompok / Kelas Resiko : Elektromedik Non Radiasi / B

Jenis Produk : Picture archiving and communications system.

Tipe / Ukuran : VITREA

Kemasan : Unit

Nama Produsen / Pabrikan : VITAL IMAGES INC., United States

-Ketentuan

1. Persetujuan izin edar berlaku sampai dengan 20 Mei 2025.

3. Izin edar ini merupakan persetujuan perpanjangan dari Nomor Izin Edar Alat Kesehatan

KEMENKES RI AKL 21501612574 tanggal 30 Juni 2016. Dengan demikian izin edar sebelumnya dinyatakan tidak berlaku.

kembali.

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.,. Distributor Nama Pabrik Nama Produk Alamat Pabrik KemenkesRI

JI. Sultan lskandar Muda Kav. 29, Kebayoran Lama, Jakarta 12240

VITAL IMAGES, INC. United States Vital Vitrea

5850 Opus Parkway, Suite 300 Minnetonka, MN USA 55343

AKL ·-·-·-·-·-·-····---···

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Vitrea

SPESIFIKASI

Server Configuration

CPU - dual processors running at 2.2 GHz or higher; Intel® Xeon™ and Dual-Core Xeon and AMD

Opteron™ Family Support; 2x dual-core Xeon 5150 processor at 2.66 GHz is recommended

Memory - 4 GB of RA,'1,1 required; 8 GB is recommended for 54-bit stand alone system

Graphics Card - NVIDIA Quadro® FX 4600 graphics card with OpenGL support

Display - 20" monitor with 1280x1024 DPI resolution is required; 1600x1200 DPI is recommended

Network Card - 100/1000 Base TX

Disk - 250 GB storage; RAID 1 or RAID 10 is recommended

Disk Drives - Floppy disk drive; 32x CDR/RW drive; 16x DVD+/RW drive is recommended Microsoft® Windows® XP Professional 32-bit/64-bit Edition Support - English Only; Windows XP 64-bit is recommended (requires Xeon processors with EMT-64 technology)

Workstation Configuration

Dual Six-Core Intel® Xeon11 _{Processor E5-2650 2.0 GHz}

32GB DDR3-1600 ECC RAM

Four (4) x 1TB 7200 RPM SATA Hard Drives in RAID 1 +O

NVIDIA® Quadro® 2000

Microsoft® Windows® 7 Professional 64-bit Edition w ith SPl or

Quad-Core Intel ® Xeon® Processor E5-1620 3.6 GHz 16 GB DDR3-1600 ECC RAM

Two (2) x 500GB 7200 RPM SATA Hard Drives in RAID 1 NVIDIA® Quadro® 2000

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ViTAL

Th• oont.<its of 1111, media ar~ a L ~ Producl of V~ol lmO;J•~. lne. oM may only t» u...d <lllCorain9

1D !h<a terms and concHtions of Iha\ llc•oJe on th~ •Y•t•m kJ<Jntlflffl:f Jfi th, !IC!ffl~ ~Qreement.

[ID °'"'""1tkm,v,;~oof<:<IJ.. ~

CE 0086

,..,J =:,,:·~·=~~~~:::&em

- M$1\i~rt~

AATG• 24Hl'33 (il 1997-20I6Vitol lma9 ... Inc., AN Ri\)111•

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KEMENTERIAN KESEHATAN REPUBLIK INDONESIA

Catatan:

NOMOR IZIN EDAR

Nama Dagang / Merek : KONICA MINOLTA MEDICAL Laser Imager

Kelompok / Kelas Resiko : Elektromedik Non Radiasi / B

Jenis Produk : Medical image hardcopy device.

Tipe / Ukuran : Dypro Sigma

Kemasan : Unit

Nama Produsen / Pabrikan : KONICA MINOLTA TECHNOPRODUCT CO. LTD., Japan

Untuk KONIKA MINOLTA INC., Japan

-Ketentuan

1. Persetujuan izin edar berlaku sampai dengan 31 Maret 2022.

3. Izin edar ini merupakan persetujuan perubahan perbaikan jenis produk dari Nomor Izin Edar Alat

Kesehatan KEMENKES RI AKL 21501312141 tanggal 6 Maret 2020. Dengan demikian izin edar sebelumnya dinyatakan tidak berlaku.

kembali.

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DRYPRO SIGMA Spec1ficat1ons ■ Laser Source

Seci,""'_'

L,35« ■ FIim Size

14'it11""(3Sx43cm) 1r , 14·12ex~cm). 11,r,,,1,n25,.30m, . erd s-~ 10· trox:?5<.m seloot31>1<>

■ Film ll<y~Jl'ISl'OO'Jl·~ f i,,SO-S, ■ Image Format 124.C.e .1,.1t.l5.IC.2£!.l4.~S6 ■ Image Memory 2GB ■ Pixel Size 7!lum ■ Processing capability

l.Jl>to45ftns ll<l< hour t14><1 7 in. (3ox43cmll

DRYPRO SIGMA Outer Dimensions

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Power-100-l 20V ± 10% i50·SOti 9A

200-240\/ :I: 10i, (50,,'EOHtr} 5A

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Distributor : PT. MURTI INDAH SENTOSA

Alamat : JI. Sultan lskandar Muda Kav. 29, Kebayoran Lama, Distributor Jakarta 12240

Nama Pabrik KONICA MINOLTA TECHNOPRODUCTS Co., ltd, Japan untuk KONICA MINOLTA

-

INC. Japan

Nama Produk : KONICA MINOLTA Laser lmager Alamat Pabrik : 2-2-1 Hirosedai, Sayama-shi, Saitama,

350-1328, Japan · Kemenkes RI : _{AKL ... ·- ···}

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From patient registration to out put to Film,

KonicaMinolta provides complete workflow.

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Compact Design

Cl!Gi'liPOO SIGMA is ~ d!Dsi<1!o11>, D)A'f las.!~

ha,;,,,. Iii. foeatures. a c0mi,ec1 ~,011,rlmt as-small , a s , ~ .. I Is, QeSl!l'l""" \YO

searo,-fiassj!Ji inresr:,:te in1i0> •>ltfi-e""i"""""ert~

when ~,inibi,edl"1i!lm!Gegili$ SlGMM .

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Four film sizes

and easy loading process

IUse!J ca, '"'"' f>m!Jc we,, mt film 11011 <lllfferel!II!

~1111>l1S!!'.i .. Oc@m t!lle tr01'lt C <i r✓ . 8<' . •et11le'le

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Rei:,itwlr,g; the- fin Cl!lrr ~" <dme v.,th, this

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and oflllmr"f!. 1n!JJi11<1" usal:!ill:Y.

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