OPTIMA URS UNIVERSAL RADIOGRAPHIC SYSTEM
FDA 510(k) clearance K012546 · decided 2001-11-02
Clearance details
- K-number
- K012546
- Device name
- OPTIMA URS UNIVERSAL RADIOGRAPHIC SYSTEM
- Applicant
- Sedecal USA, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-08-07
- Decision date
- 2001-11-02
- Days to decision
- 87 days
- Clearance type
- Traditional
- Product code
- KPR
- Device class
- 2
- Regulation number
- 892.1680
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Deer Field, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Sedecal X Optima URS digital mobile diagnostic x-ray system. A a stationary x-ray unit wit recall (Z-0781-2024) | SEDECAL SA | 2024-01-23 |
| Optima URS X-Ray System; Manufactured by SEDECAL, C/Pelya 9 Pol. Ind. Rio De Janeiro, 2811 recall (Z-0652-03) | Sedecal USA, Inc. | 2003-04-25 |