BELLYBOARD, SBRT ACCESSORIES
FDA 510(k) clearance K121545 · decided 2012-06-08
Clearance details
- K-number
- K121545
- Device name
- BELLYBOARD, SBRT ACCESSORIES
- Applicant
- Medtec Inc. Dba Civco Medical Solutions
- Decision
- Substantially Equivalent
- Date received
- 2012-05-25
- Decision date
- 2012-06-08
- Days to decision
- 14 days
- Clearance type
- Traditional
- Product code
- LNH
- Device class
- 2
- Regulation number
- 892.1000
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Orange City, IA, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Civco Belly Board, Reusable non-sterile carbon fiber belly board with cushion, REF 125012, recall (Z-0802-2014) | Civco Medical Instruments Inc | 2014-01-21 |
| Civco Belly Board MRI, Reusable non-sterile glass fiber belly board with cushion, REF 1260 recall (Z-0803-2014) | Civco Medical Instruments Inc | 2014-01-21 |