ORTHOPACS
FDA 510(k) clearance K033825 · decided 2004-02-02
Clearance details
- K-number
- K033825
- Device name
- ORTHOPACS
- Applicant
- Etrauma.Com Corp.
- Decision
- Substantially Equivalent
- Date received
- 2003-12-10
- Decision date
- 2004-02-02
- Days to decision
- 54 days
- Clearance type
- Traditional
- Product code
- LLZ
- Device class
- 2
- Regulation number
- 892.2050
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Hopkonton, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Merge OfficePACS software. The firm name on the label is Merge Healthcare, Heartland, WI. recall (Z-2159-2016) | Merge Healthcare, Inc. | 2016-07-11 |
| Merge OfficePACS software. The firm name on the label is Merge Healthcare, Hartland, WI. O recall (Z-2144-2016) | Merge Healthcare, Inc. | 2016-07-08 |