Atlas FDA

HD15 DIAGNOSTIC ULTRASOUND SYSTEM

FDA 510(k) clearance K081661 · decided 2008-06-24

Clearance details

K-number
K081661
Device name
HD15 DIAGNOSTIC ULTRASOUND SYSTEM
Applicant
Philips Ultrasound, Inc.
Decision
Substantially Equivalent
Date received
2008-06-13
Decision date
2008-06-24
Days to decision
11 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
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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 L12-5 Ultrasound Transducer recall (Z-1620-2026)Philips Ultrasound, Inc2026-03-24
Philips OMNI III TEE Ultrasound Transducer recall (Z-1624-2026)Philips Ultrasound, Inc2026-03-24
Philips S5-2 Ultrasound Transducer recall (Z-1626-2026)Philips Ultrasound, Inc2026-03-24
3D9-3v Transducer Probe recall (Z-2347-2025)Philips Ultrasound, Inc2025-08-22
BP10-5ec Transducer Probe recall (Z-2349-2025)Philips Ultrasound, Inc2025-08-22
C5-2 Transducer Probe recall (Z-2353-2025)Philips Ultrasound, Inc2025-08-22
C6-3 Transducer Probe recall (Z-2356-2025)Philips Ultrasound, Inc2025-08-22
C8-4v Transducer Probe recall (Z-2357-2025)Philips Ultrasound, Inc2025-08-22
C8-4v Transducer Probe recall (Z-2358-2025)Philips Ultrasound, Inc2025-08-22
C8-5 Transducer Probe recall (Z-2359-2025)Philips Ultrasound, Inc2025-08-22
D2cwc Transducer Probe recall (Z-2366-2025)Philips Ultrasound, Inc2025-08-22
L12-3 Transducer Probe recall (Z-2372-2025)Philips Ultrasound, Inc2025-08-22
L12-5 50 Transducer Probe recall (Z-2376-2025)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
S5-2 Transducer Probe recall (Z-2394-2025)Philips Ultrasound, Inc2025-08-22
S7-2t Transducer Probe recall (Z-2396-2025)Philips Ultrasound, Inc2025-08-22
S8-3 Transducer Probe recall (Z-2397-2025)Philips Ultrasound, Inc2025-08-22
V6-2 Transducer Probe recall (Z-2403-2025)Philips Ultrasound, Inc2025-08-22
Philips 3D9-3v Transducer. recall (Z-2048-2025)Philips Ultrasound, Inc2025-07-02
Philips C5-2 Transducer. recall (Z-2050-2025)Philips Ultrasound, Inc2025-07-02
Philips L12-3 Transducer. recall (Z-2054-2025)Philips Ultrasound, Inc2025-07-02
Philips S7-2 Transducer. recall (Z-2059-2025)Philips Ultrasound, Inc2025-07-02
Philips V6-2 Transducer. recall (Z-2062-2025)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