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Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 30 Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System

FDA 510(k) clearance K172607 · decided 2017-10-04

Clearance details

K-number
K172607
Device name
Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 30 Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System
Applicant
Philips Health Care
Decision
Substantially Equivalent
Date received
2017-08-30
Decision date
2017-10-04
Days to decision
35 days
Clearance type
Traditional
Product code
IYN
Device class
2
Regulation number
892.1550
Medical specialty
Radiology
Advisory committee
Radiology
Location
Bothell, WA, US
Third-party review
Yes
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Venue Go (K261668)GE Medical Systems Ultrasound and Primary care Diagnostics, LLC2026-08-07
Alturion Series Diagnostic Ultrasound System (K262311)Philips Ultrasound, LLC2026-08-04
LOGIQ Focus (K261835)GE Medical Systems Ultrasound and Primary Care Diagnostics2026-07-30
Handheld Ultrasound Scanner (K261288)IMGFAX CO., LTD.2026-07-30
V8/XV8/XH8/H8/cV8/V8 ONE/XV8 ONE/XH8 ONE/H8 ONE/cV8 ONE Diagnostic Ultrasound System; V7/XV7/XH7/H7/cV7/V7 ONE/XV7 ONE/H7 ONE/XH7 ONE/cV7 ONE Diagnostic Ultrasound System; V6/XV6/XH6/H6/cV6/V6 ONE/XV6 ONE/H6 ONE/XH6 ONE/cV6 ONE Diagnostic Ultrasound System; V5/XV5/XH5/H5/cV5 Diagnostic Ultrasound System; V4/XV4/XH4/H4/cV4 Diagnostic Ultrasound System; (K261412)Samsung Medison Co., Ltd.2026-07-28
Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic Ultrasound System (K261211)Philips Ultrasound, LLC2026-07-27
Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro) (K261081)Beijing Konted Medical Technology Co.,Ltd2026-07-23
ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/ MOZI-X1/ MOZI-X12/ DF-41E Diagnostic ultrasound system (K261272)Esonic Technology (Wuhan) Co., Ltd.2026-07-23
Alturion Series Diagnostic Ultrasound System (K260667)Philips Ultrasound, LLC2026-06-29
ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound System;ACUSON Origin Diagnostic Ultrasound System;ACUSON Origin ICE Diagnostic Ultrasound System (K260844)Siemens Medical Solutions USA, Inc.2026-06-16
ES-Series (K260748)E-Scopics2026-06-09
EPIQ Series Diagnostic Ultrasound System (K260123)Philips Ultrasound, LLC2026-05-27

Recalls involving this device

RecordFirmDate
Philips Mini Multi TEE Ultrasound Transducer recall (Z-1622-2026)Philips Ultrasound, Inc2026-03-24
Philips X7-2 Ultrasound Transducer recall (Z-1628-2026)Philips Ultrasound, Inc2026-03-24
BP10-5ec Transducer Probe recall (Z-2349-2025)Philips Ultrasound, Inc2025-08-22
C10-3v Transducer Probe recall (Z-2350-2025)Philips Ultrasound, Inc2025-08-22
C10-4ec Transducer Probe recall (Z-2351-2025)Philips Ultrasound, Inc2025-08-22
C6-2 Transducer Probe recall (Z-2355-2025)Philips Ultrasound, Inc2025-08-22
C9-2 Transducer Probe recall (Z-2360-2025)Philips Ultrasound, Inc2025-08-22
C9-4v Transducer Probe recall (Z-2364-2025)Philips Ultrasound, Inc2025-08-22
D2TCD Transducer Probe recall (Z-2367-2025)Philips Ultrasound, Inc2025-08-22
L18-5 Transducer Probe recall (Z-2380-2025)Philips Ultrasound, Inc2025-08-22
Mini Multi TEE Transducer Probe recall (Z-2385-2025)Philips Ultrasound, Inc2025-08-22
S4-2 Transducer Probe recall (Z-2393-2025)Philips Ultrasound, Inc2025-08-22
S7-3t Transducer Probe recall (Z-2395-2025)Philips Ultrasound, Inc2025-08-22
S8-3t Transducer Probe recall (Z-2398-2025)Philips Ultrasound, Inc2025-08-22
TRANSDUCER L12-5 Transducer Probe recall (Z-2402-2025)Philips Ultrasound, Inc2025-08-22
VL13-5 Transducer Probe recall (Z-2405-2025)Philips Ultrasound, Inc2025-08-22
X5-1 Transducer Probe recall (Z-2408-2025)Philips Ultrasound, Inc2025-08-22
X6-1 Transducer Probe recall (Z-2410-2025)Philips Ultrasound, Inc2025-08-22
X7-2 Transducer Probe recall (Z-2411-2025)Philips Ultrasound, Inc2025-08-22
X8-2t Transducer Probe recall (Z-2413-2025)Philips Ultrasound, Inc2025-08-22
XL14-3 Transducer Probe recall (Z-2414-2025)Philips Ultrasound, Inc2025-08-22
Philips eL18-4 Transducer. recall (Z-2052-2025)Philips Ultrasound, Inc2025-07-02
Philips eL18-4 EMT Transducer. recall (Z-2053-2025)Philips Ultrasound, Inc2025-07-02
Philips S7-3t Transducer. recall (Z-2060-2025)Philips Ultrasound, Inc2025-07-02
Philips S8-3t Transducer. recall (Z-2061-2025)Philips Ultrasound, Inc2025-07-02
Philips VL13-5 Transducer. recall (Z-2063-2025)Philips Ultrasound, Inc2025-07-02
Philips X5-1 Transducer. recall (Z-2064-2025)Philips Ultrasound, Inc2025-07-02
Philips X6-1 Transducer. recall (Z-2065-2025)Philips Ultrasound, Inc2025-07-02
Philips X8-2t Transducer. recall (Z-2067-2025)Philips Ultrasound, Inc2025-07-02
Philips XL14-3 Transducer. recall (Z-2068-2025)Philips Ultrasound, Inc2025-07-02