Atlas FDA

EPIQ DIAGNOSTIC ULTRASOUND SYSTEM

FDA 510(k) clearance K132304 · decided 2013-08-21

Clearance details

K-number
K132304
Device name
EPIQ DIAGNOSTIC ULTRASOUND SYSTEM
Applicant
Philips Ultrasound, Inc.
Decision
Substantially Equivalent
Date received
2013-07-24
Decision date
2013-08-21
Days to decision
28 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
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
c5-1 Transducer Probe recall (Z-2352-2025)Philips Ultrasound, Inc2025-08-22
C8-5 Transducer Probe recall (Z-2359-2025)Philips Ultrasound, Inc2025-08-22
C9-2 Transducer Probe recall (Z-2360-2025)Philips Ultrasound, Inc2025-08-22
D2TCD Transducer Probe recall (Z-2367-2025)Philips Ultrasound, Inc2025-08-22
L15-7io Transducer Probe recall (Z-2377-2025)Philips Ultrasound, Inc2025-08-22
L15-7IO TRANSDUCER Transducer Probe recall (Z-2378-2025)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
S12-4 Transducer Probe recall (Z-2389-2025)Philips Ultrasound, Inc2025-08-22
S7-3t Transducer Probe recall (Z-2395-2025)Philips Ultrasound, Inc2025-08-22
S8-3 Transducer Probe recall (Z-2397-2025)Philips Ultrasound, Inc2025-08-22
TRANSDUCER L12-5 Transducer Probe recall (Z-2402-2025)Philips Ultrasound, Inc2025-08-22
V6-2 Transducer Probe recall (Z-2403-2025)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
X7-2t Transducer Probe recall (Z-2412-2025)Philips Ultrasound, Inc2025-08-22
Philips C5-1 Transducer. recall (Z-2049-2025)Philips Ultrasound, Inc2025-07-02
Philips S7-3t Transducer. recall (Z-2060-2025)Philips Ultrasound, Inc2025-07-02
Philips V6-2 Transducer. recall (Z-2062-2025)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 X7-2t Transducer. recall (Z-2066-2025)Philips Ultrasound, Inc2025-07-02
3D9-3v Transducer, accessory to Philips Ultrasound Systems: EPIQ Elite; Affiniti 30, 50, a recall (Z-2517-2023)Philips Ultrasound, Inc.2023-09-06
EPIQ 5 Ultrasound System versions 1.3.2 or lower, WITHOUT the Pediatric Cardiology option, recall (Z-1631-2015)Philips Ultrasound, Inc.2015-05-19
EPIQ 7 Ultrasound System versions 1.3.2 or lower, WITHOUT the Pediatric Cardiology option, recall (Z-1632-2015)Philips Ultrasound, Inc.2015-05-19
EPIQ 5 Ultrasound System with Pediatric Cardiology option, Model: EPIQ 5G, EPIC 5C, EPIQ 5 recall (Z-1578-2015)Philips Ultrasound, Inc.2015-05-05
EPIQ 7 Ultrasound System with Pediatric Cardiology option, Model: EPIQ 7G, EPIC 7C, EPIQ 7 recall (Z-1579-2015)Philips Ultrasound, Inc.2015-05-05
EPIQ 5 Ultrasound System, EPIQ 5 systems with software versions 1.0.x or 1.1.x with QLAB a recall (Z-0816-2015)Philips Ultrasound, Inc.2014-12-16
EPIQ 7 Ultrasound System, EPIQ 7 systems with software versions 1.0.x or 1.1.x with QLAB a recall (Z-0817-2015)Philips Ultrasound, Inc.2014-12-16
Philips Model EPIQ 5 Ultrasound System. Intended for diagnostic ultrasound imaging and flu recall (Z-1263-2014)Philips Medical Systems North America Inc.2014-03-20
Philips Model EPIQ 7 Ultrasound System. Intended for diagnostic ultrasound imaging and flu recall (Z-1264-2014)Philips Medical Systems North America Inc.2014-03-20
EPIQ 7 Ultrasound System, Model 795200, 795201, 795202. Intended for diagnostic ultrasound recall (Z-0368-2014)Philips Medical Systems North America Inc.2013-11-20