KEMENTERIAN KESEHATAN REPUBLIK INDONESIA

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Jakarta, 14 Mei 2021

Catatan:

- UU ITE No 11 Tahun 2008 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 21501817460

Nama Dagang / Merek :

EPIQ CVx Diagnostic Ultrasound System

Kelompok / Kelas Resiko : Elektromedik Non Radiasi / B

Kategori Produk : Peralatan Radiologi

Sub Kategori : Peralatan Radiologi Diagnostik

Jenis Produk : Ultrasonic pulsed doppler imaging system.

Tipe / Ukuran : EPIQ CVx

Kemasan : Unit

Nama Produsen / Pabrikan : PHILIPS ULTRASOUND, INC., United States

Nama Pendaftar : PT. PHILIPS INDONESIA COMMERCIAL, DKI Jakarta Atas dasar lisensi dari : -

Ketentuan

1. Persetujuan izin edar berlaku sampai dengan 29 April 2025.

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 perubahan aksesori dari Nomor Izin Edar Alat Kesehatan KEMENKES RI AKL 21501817460 tanggal 1 Februari 2021. 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

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:

LAMPIRAN

NOMOR IZIN EDAR

ALAT KESEHATAN

KEMENKES RI AKL 21501817460

No. Deskripsi Tipe / Kode

1 3D9-3v 989605395622

2 C5-1 989605412042

3 C8-5 989605391921

4 C9-2 989605391092

5 C10-3v 989605409562

6 C10-4ec 989605413712

7 D2cwc 989605412052

8 D2tcd 989605412102

9 D5cwc 989605412062

10 eL18-4 989605456291

11 L12-3 / L-12-3 ERGO 989605412072

12 L12-5 50MM / L12-5 989605418552

13 L15-7io 989605387853

14 L18-5 989605409582

15 mC7-2 989605486021

16 mC12-3 989605495721

17 S5-1 989605412082

18 S7-3t 989605406772

19 S8-3 989605361882

20 S8-3t 989605431171

21 S9-2 989605472101

22 S12-4 989605361892

23 X5-1 989605400802

24 X5-1C 989606702251

25 X6-1 989605409282

26 X7-2 989605400812

27 X7-2t 989605414122

28 X8-2t 989605455171

29 XL14-3 989605409251

30 VL13-5 989605409592

31 V6-2 989605437982

32 V9-2 989606717071

33 Pediatric ECG Leads 989605405911

34 Adult ECG Leads 989605405891

35 C5-1 Biopsy Kit, Infinity 989605413381

36 C5-1 Biopsy Kit 989605369041

37 C8-4v/C9-3v Biopsy Kit, Disposable 989605379751

38 C9-2 Biopsy Kit, Disposable 989605427781

39 C9-2 Biopsy Kit, Reusable 989605427791

Lampiran 1 dari 3 Halaman

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Catatan:

40 C9-4ec Biopsy Kit, Disposable 989605418481

41 C9-4ec Biopsy Kit, Reusable 989605418471

42 L12-3 Biopsy Kit 989605384321

43 L12-5 50 Biopsy Kit 8500-9089-03

44 L17-5 Biopsy Kit 989605341541

45 S5-2 Biopsy Kit, Steel 989605377471

46 S5-2/S5-1 Biopsy Kit 989605384331

47 X6-1 Biopsy Kit 989605397421

48 Biopsy Kit, 3D9-3v 989605351091

49 B/G Starter Kit, V6-2 989605361861

50 B/G Starter Kit, VL13-5 989605377711

51 B/G STARTER KIT,C8-5 989605464261

52 Biopsy Guide, Steel S5-2 989605449331

53 C9-2 Verza Biopsy Guide 989605464151

54 C5-1 Verza Biopsy Guide 989605464141

55 L12-3 Verza Biopsy Guide 989605464171

56 L12-5 50 Verza Biopsy Guide 989605464201

57 mC7-2 Verza Biopsy Guide 989605486041

58 X6-1 Verza Biopsy Guide 989605464161

59 V9-2 Verza Biopsy Guide 989605486051

60 xL14-3 Verza Biopsy Guide 989605464191

61 PercuNav Tracking Bracket Kit, C5-1 989605418932

62 PercuNav Tracking Bracket Kit, C9-2 989605435142

63 PercuNav Tracking Bracket Kit, C10-4ec 989605435132

64 PercuNav Tracking Bracket Kit, L12-5 989605418952

65 PercuNav Tracking Bracket Kit, X6-1 989605418942

66 30001, PNAV BX KIT C5-1 989605418932

67 30002, PNAV BX KIT X6-1 989605418942

68 30003, PNAV BX KIT L12-5 989605418952

69 30004, PNAV BX KIT C9-2 989605435142

70 30006, PNAV BX KIT S5-1 989605442881

71 Civco eTRAX Sensor 12G 989605458521

72 Civco eTRAX Sensor 14G 989605458531

73 Civco eTRAX Sensor 16G 989605458541

74 Civco eTRAX Sensor 18G 989605458551

75 ASUS Japan Wireless Adapter 989605464111

76 ASUS Dual Band Wireless Adapter 989605464891

77 Linksys 2.0 Dual Band Wireless Adapter 989605464901

78 Rivet Wireless Configuration Kit 989605470281

79 DVR External, NTSC 989605447601

80 DVR External, PAL 989605447611

81 DVR External 989605406761

82 Color Printer External 989605406742

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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:

83 B/W Printer External 989605406752

84 DVR Internal 989605406731

85 Color Printer Internal 989605406711

86 B/W Printer Internal 989605406721

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

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EPIQCVxDiagnosticUltrasoundSystem

NomorSeri:lihatpenandaanutamaberbahasaInggris

Diproduksioleh:

PhilipsUltrasound,Inc.

22100BothellͲEverettHighway

Bothell,WA98021USA

Diimpordandidistribusikanoleh:

PTPhilipsIndonesiaCommercial

GedungCibisNineLantai10

Jl.TBSimatupangNo.2,Jakarta12560,Indonesia

KEMENKESRIAKL

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VMQ 7.0 Technical Data Sheet (TDS)

1 Product Description:

In support of the Ultrasound strategic roadmap, the VMQ 7.0 program will be a Cardiovascular focused release to introduce new innovation to the market, as well as bolstering the current offerings. All models of both EPIQ and Affiniti will be supported for this release.

VMQ 7.0 will include growth opportunities in Premium Cardiology with the addition of GPU beamforming on X5-1C. VMQ 7.0 provides continued Premium growth in Adult and Pediatric Cardiology with the introduction of the X5-1C on the EPIQ CVx/CVxi. Additionally, the introduction of an Affiniti CVx product will deliver meaningful innovation for HE cardiology customer.

The program will also manage the preparation for submittal of VMQ 7.0 content, as well as a release with whatever content has been cleared by China NMPA. To emphasize the programs commitment to CONQ, this release will be increasing MTBSE for EPIQ to 400 days @ 6 months, and Affiniti to 700 days @ 6 months.

The DHF for this product can be found in eMatrix: 000750.

2 Project Objectives:

x Release a new product (Affiniti CVx) with 2 new configurations (AE, SE) positioned at the same level as Affiniti 70C. No new HW. Does not include the ability to field upgrade.

x Release innovative Premium Cardiology solutions to sustain growth and reduce competitive gaps in Q2 2020

x Release the Advanced Cardiology focused UI on Affiniti (CVx/70C/70G/50C/50G) to support High-End Cardiac markets by Q3 2020.

x Release for limited distribution with X5-1c & C-cart.

6 Major Hardware Features:

x Modified badging to distinguish Affiniti CVx from Affiniti 70C/50C

x Modification to existing ACB for software beam forming (Support second Graphics Card, will replace only EPIQ CVx and EPIQ 7C/5C versions of ACB in production) EPIQ only

x IMB3 for software beam forming (will replace only EPIQ CVx and EPIQ CVxi versions of IMB in production).

x Second Graphics Card (Nvidia P4000) for GPU Software Beam Forming

x EPIQ CVxi new Echo Connection Box (ECB) (works with B & C Carts)

x Fusion Physio (Works with B & C Carts).

(Major hardware components will be included in the first phase of CSA witness testing).

7 Major Software, Application Features:

x Affiniti CVx Product (Single product config w/ Standard and Advanced cores, Badging, UI)

x SWBF (EPIQ CVx/CVxi for X5-1C) (limited distribution) x EchoNav Touch infrastructure

x 3D Auto MV (requires 510(k) submission) x Live iSlice

x Unlock XPlane

x X8-2t on Affiniti CVx and A70 C&G only x 3D Color Interleave

x Auto LAA

x 3D Performance Enhancements (IQ, Volume Rate) x IQ Enhancements on EPIQ and Affiniti

x TrueVue Color / Glass View (X8-2t) x 3D Zoom & WF on EPIQ & Affiniti x Advanced Cardiology UI on Affiniti

CVx/70C/70G/50C/50G

x Migrate AutoStrain LV to Affiniti 30

x Release Epiq CVx/Elite/EliteW/7/5/7C/5C China Configurations

8 Major Transducer Features:

x X5-1C (EPIQ CVx (3D & 2D Core) Require C.0 HW) (X5-1c will be included in the second phase of CSA witness testing).

9 Major Connectivity Features:

x Configurable DICOM SR output for legacy PAC EPIQ 5/7/CVx/CVxi Affiniti CVx 70/50/30 QLAB/Q-Station

EPIQCVxDiagnosticUltrasoundSystem

NomorSeri:lihatpenandaanutamaberbahasaInggris

Diproduksioleh:

PhilipsUltrasound,Inc.

22100BothellͲEverettHighway

Bothell,WA98021USA

Diimpordandidistribusikanoleh:

PTPhilipsIndonesiaCommercial

GedungCibisNineLantai10

Jl.TBSimatupangNo.2,Jakarta12560,Indonesia

KEMENKESRIAKL

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x X5-1C requires the C-cart where the C-cart includes IMB3 Coffee Lake, Nvidia P4000 GPU, and Harmony ACB x CVx and CVxi production (including CVx 2D) C-cart will be

limited distribution only when X5-1c is ordered.

x CV TrueVue remains a purchasable option and still includes P2000 GPU

x No consideration for additional 2D/3D performance boost when CV TrueVue purchased

x Harmony ACB will be manufactured by Flextronic. The Core Team will manage the design transfer.

x Program includes releasing China configurations in preparation for the EPIQ VMQ5.0 NMPA cleared systems.

x Program will execute Type Testing in preparation for 7.0 NMPA submission for several CV configurations

4 Priority of Scope/Schedule/Cost:

1. Schedule: Business and financial expectations to adhere to a two release per year cadence is driving a Q3 2020 release.

2. Cost: Project Costs (FTE/non-FTE) must adhere to AOP budgets and an acceptable payback period

3. Scope: Release “MVP Feature” to align with Strategic Roadmap, with content to ensure viable offering and ROI

5 Compatibility:

The VMQ 7.0 Software will be compatible with the following hardware configurations.

VMQ 7.0 Compatibility Matrix

Software Hardware Configurations

A.x B.x C.0

3.0.x X X

4.0.x X X

5.0.x X X

6.0.x X X

7.0 X X X

Schedule Budget including X5-

1C)

x PI 10/08/18 2018: $7.6M

x VPA-R 12/11/18 2019: $14.9M x PDC-R: 03/05/19 2020: $5.4M x PLC-R: 12/11/19 Total: $27.9, €23.9*

x SVER-R: 05/4/20

x RfA-R 5/19/20 * Exchange Rate: 0.8551 x SVAL-R: 07/03/20

x SR-R: 07/24/20 x RfD: 08/28/20

12 Regulatory Impact of Project:

x 510(k) submission is required for 3D Auto MV.

Country Submission Clearance Date EU, Australia, New

Zealand, India

Self-Certification RFD

China CFDA Registration RFD + 15-16 Months

USA 510k RFD + 1-3 Months

Canada Health Canada RFD + 4-6 Months Latin America MOH Submissions RFD + 6-12 Months Singapore HSA Change

Notification

RFD + 4-6 Months

South Korea KFDA Submission RFD + 5-7 Months