Atlas FDA

CX50 3.0 DIAGNOSTIC ULTRASOUND SYSTEM

FDA 510(k) clearance K123754 · decided 2012-12-21

Clearance details

K-number
K123754
Device name
CX50 3.0 DIAGNOSTIC ULTRASOUND SYSTEM
Applicant
Philips Ultrasound, Inc.
Decision
Substantially Equivalent
Date received
2012-12-06
Decision date
2012-12-21
Days to decision
15 days
Clearance type
Traditional
Product code
IYN
Device class
2
Regulation number
892.1550
Medical specialty
Radiology
Advisory committee
Radiology
Location
Andover, MA, 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.

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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
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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
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Recalls involving this device

RecordFirmDate
Philips L12-5 Ultrasound Transducer recall (Z-1620-2026)Philips Ultrasound, Inc2026-03-24
C10-3v Transducer Probe recall (Z-2350-2025)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
C9-3io Transducer Probe recall (Z-2361-2025)Philips Ultrasound, Inc2025-08-22
C9-3v Transducer Probe recall (Z-2362-2025)Philips Ultrasound, Inc2025-08-22
D2cwc Transducer Probe recall (Z-2366-2025)Philips Ultrasound, Inc2025-08-22
D5cwc Transducer Probe recall (Z-2368-2025)Philips Ultrasound, Inc2025-08-22
eL18-4 Transducer Probe recall (Z-2369-2025)Philips Ultrasound, Inc2025-08-22
L10-4LAP Transducer Probe recall (Z-2370-2025)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
S12-4 Transducer Probe recall (Z-2389-2025)Philips Ultrasound, Inc2025-08-22
S8-3 Transducer Probe recall (Z-2397-2025)Philips Ultrasound, Inc2025-08-22
Transducer C10-3v Transducer Probe recall (Z-2401-2025)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 L12-3 Transducer. recall (Z-2054-2025)Philips Ultrasound, Inc2025-07-02
Philips S5-1 Transducer. recall (Z-2058-2025)Philips Ultrasound, Inc2025-07-02
Philips X7-2t Transducer. recall (Z-2066-2025)Philips Ultrasound, Inc2025-07-02