510(k) K030455 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
BORIS PLATFORM DIAGNOSTIC ULTRASOUND SYSTEM
| Applicant | Philips Ultrasound, Inc., Bothell WA, US |
| Decision | Substantially Equivalent, Mar 13, 2003 |
| Received | Feb 11, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K030455
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 24, 2026 | Philips Ultrasound, Inc Philips C9-4 Ultrasound Transducer Open, Classified |
ITX | None listed |
| Mar 24, 2026 | Philips Ultrasound, Inc Philips L12-5 Ultrasound Transducer Open, Classified |
ITX | None listed |
| Mar 24, 2026 | Philips Ultrasound, Inc Philips L17-5 Ultrasound Transducer Open, Classified |
ITX | None listed |
| Mar 24, 2026 | Philips Ultrasound, Inc Philips S4-1 Ultrasound Transducer Open, Classified |
ITX | None listed |
| Aug 22, 2025 | Philips Ultrasound, Inc C5-2 Transducer Probe Open, Classified |
IYN | None listed |
| Aug 22, 2025 | Philips Ultrasound, Inc C8-4v Transducer Probe Open, Classified |
IYN | None listed |
| Aug 22, 2025 | Philips Ultrasound, Inc C8-4v Transducer Probe Open, Classified |
IYN | None listed |
| Aug 22, 2025 | Philips Ultrasound, Inc C8-5 Transducer Probe Open, Classified |
IYN | None listed |
| Aug 22, 2025 | Philips Ultrasound, Inc C9-4 Transducer Probe Open, Classified |
IYN | None listed |
| Aug 22, 2025 | Philips Ultrasound, Inc C9-5ec Transducer Probe Open, Classified |
IYN | None listed |
| Aug 22, 2025 | Philips Ultrasound, Inc D2cwc Transducer Probe Open, Classified |
IYN | None listed |
| Aug 22, 2025 | Philips Ultrasound, Inc D2TCD Transducer Probe Open, Classified |
IYN | None listed |
| Aug 22, 2025 | Philips Ultrasound, Inc D5cwc Transducer Probe Open, Classified |
IYN | None listed |
| Aug 22, 2025 | Philips Ultrasound, Inc L11-3 Transducer Probe Open, Classified |
IYN | None listed |
| Aug 22, 2025 | Philips Ultrasound, Inc L12-5 50 Transducer Probe Open, Classified |
IYN | None listed |
| Aug 22, 2025 | Philips Ultrasound, Inc L15-7io Transducer Probe Open, Classified |
IYN | None listed |
| Aug 22, 2025 | Philips Ultrasound, Inc L15-7IO TRANSDUCER Transducer Probe Open, Classified |
IYN | None listed |
| Aug 22, 2025 | Philips Ultrasound, Inc L17-5 Transducer Probe Open, Classified |
IYN | None listed |
| Aug 22, 2025 | Philips Ultrasound, Inc L8-4 Transducer Probe Open, Classified |
IYN | None listed |
| Aug 22, 2025 | Philips Ultrasound, Inc L9-3 Transducer Probe Open, Classified |
IYN | None listed |
| Aug 22, 2025 | Philips Ultrasound, Inc S3-1 Transducer Probe Open, Classified |
IYN | None listed |
| Aug 22, 2025 | Philips Ultrasound, Inc S4-1 Transducer Probe Open, Classified |
IYN | None listed |
| Aug 22, 2025 | Philips Ultrasound, Inc TRANSDUCER L12-5 Transducer Probe Open, Classified |
IYN | None listed |
| Jul 2, 2025 | Philips Ultrasound, Inc Philips C5-2 Transducer. Open, Classified |
ITX | None listed |
| Jul 2, 2025 | Philips Ultrasound, Inc Philips C9-5EC Transducer. Open, Classified |
ITX | None listed |
| Jul 2, 2025 | Philips Ultrasound, Inc Philips L8-4 Transducer. Open, Classified |
ITX | None listed |
| Jul 2, 2025 | Philips Ultrasound, Inc Philips L9-3 Transducer. Open, Classified |
ITX | None listed |
| Aug 30, 2019 | Philips Ultrasound Inc Transducer S7-3t
UDI (01)00884838067530
REF 989605439232
Used as accessory with: iE33, HD11 Ultrasound Systems - Product Usage: Diagnostic ultrasound imaging or fluid flow analysis of the human body Terminated |
ITX | None listed |
| Aug 30, 2019 | Philips Ultrasound Inc Transducer S8-3t
UDI (01)00884838067523
REF 989605420183
Can be used with: iE33 Utrasound System - Product Usage: Diagnostic ultrasound imaging or fluid flow analysis of the human body - particularl Terminated |
ITX | None listed |
| Apr 25, 2011 | Philips Medical Systems Nederlands S8-3t Micro TEE Transducer is an Ultrasonic Diagnostic. The Part # is 989605379471.
The User information is labeled in part: "***iE33 Ultrasound System ***User Information Update***4535 614 04811 Re Terminated |
IYN | None listed |
| Feb 17, 2007 | Philips Ultrasound, Inc. iE33 Ultrasound System (System, imaging, pulsed doppler, ultrasonic and system, imaging, pulsed echo, ultrasonic) Terminated |
IYN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.