HP ENDOVAGINAL/ENDORECTAL PROBE, HP IMAGE POINT ULTRASOUND SYSTEM
FDA 510(k) clearance K972348 · decided 1997-07-24
Clearance details
- K-number
- K972348
- Device name
- HP ENDOVAGINAL/ENDORECTAL PROBE, HP IMAGE POINT ULTRASOUND SYSTEM
- Applicant
- Hewlett-Packard Co.
- Decision
- Substantially Equivalent
- Date received
- 1997-06-24
- Decision date
- 1997-07-24
- Days to decision
- 30 days
- Clearance type
- Traditional
- Product code
- ITX
- Device class
- 2
- Regulation number
- 892.1570
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Andover, MA, US
- Third-party review
- No
- 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 |