Atlas FDA

BORIS PLATFORM DIAGNOSTIC ULTRASOUND SYSTEM

FDA 510(k) clearance K030455 · decided 2003-03-13

Clearance details

K-number
K030455
Device name
BORIS PLATFORM DIAGNOSTIC ULTRASOUND SYSTEM
Applicant
Philips Ultrasound, Inc.
Decision
Substantially Equivalent
Date received
2003-02-11
Decision date
2003-03-13
Days to decision
30 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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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 C9-4 Ultrasound Transducer recall (Z-1619-2026)Philips Ultrasound, Inc2026-03-24
Philips L12-5 Ultrasound Transducer recall (Z-1620-2026)Philips Ultrasound, Inc2026-03-24
Philips L17-5 Ultrasound Transducer recall (Z-1621-2026)Philips Ultrasound, Inc2026-03-24
Philips S4-1 Ultrasound Transducer recall (Z-1625-2026)Philips Ultrasound, Inc2026-03-24
C5-2 Transducer Probe recall (Z-2353-2025)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
C9-4 Transducer Probe recall (Z-2363-2025)Philips Ultrasound, Inc2025-08-22
C9-5ec Transducer Probe recall (Z-2365-2025)Philips Ultrasound, Inc2025-08-22
D2cwc Transducer Probe recall (Z-2366-2025)Philips Ultrasound, Inc2025-08-22
D2TCD Transducer Probe recall (Z-2367-2025)Philips Ultrasound, Inc2025-08-22
D5cwc Transducer Probe recall (Z-2368-2025)Philips Ultrasound, Inc2025-08-22
L11-3 Transducer Probe recall (Z-2371-2025)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
L17-5 Transducer Probe recall (Z-2379-2025)Philips Ultrasound, Inc2025-08-22
L8-4 Transducer Probe recall (Z-2381-2025)Philips Ultrasound, Inc2025-08-22
L9-3 Transducer Probe recall (Z-2382-2025)Philips Ultrasound, Inc2025-08-22
S3-1 Transducer Probe recall (Z-2390-2025)Philips Ultrasound, Inc2025-08-22
S4-1 Transducer Probe recall (Z-2391-2025)Philips Ultrasound, Inc2025-08-22
TRANSDUCER L12-5 Transducer Probe recall (Z-2402-2025)Philips Ultrasound, Inc2025-08-22
Philips C5-2 Transducer. recall (Z-2050-2025)Philips Ultrasound, Inc2025-07-02
Philips C9-5EC Transducer. recall (Z-2051-2025)Philips Ultrasound, Inc2025-07-02
Philips L8-4 Transducer. recall (Z-2056-2025)Philips Ultrasound, Inc2025-07-02
Philips L9-3 Transducer. recall (Z-2057-2025)Philips Ultrasound, Inc2025-07-02
S8-3t Micro TEE Transducer is an Ultrasonic Diagnostic. The Part # is 989605379471. The Us recall (Z-2062-2011)Philips Medical Systems Nederlands2011-04-25
iE33 Ultrasound System (System, imaging, pulsed doppler, ultrasonic and system, imaging, p recall (Z-0422-2007)Philips Ultrasound, Inc.2007-02-17