SONOS 5500 IMAGING SYSTEM M2424A VERSION B.O
FDA 510(k) clearance K990339 · decided 1999-02-18
Clearance details
- K-number
- K990339
- Device name
- SONOS 5500 IMAGING SYSTEM M2424A VERSION B.O
- Applicant
- Hewlett-Packard Co.
- Decision
- Substantially Equivalent
- Date received
- 1999-02-03
- Decision date
- 1999-02-18
- 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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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| 7.5MHZ Endo Transducer Probe recall (Z-2348-2025) | Philips Ultrasound, Inc | 2025-08-22 |