VARIAN/XIMATRON 5 CARBON-FIBER COUCH TOP
FDA 510(k) clearance K851653 · decided 1985-05-23
Clearance details
- K-number
- K851653
- Device name
- VARIAN/XIMATRON 5 CARBON-FIBER COUCH TOP
- Applicant
- Varian Assoc., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-04-22
- Decision date
- 1985-05-23
- Days to decision
- 31 days
- Clearance type
- Traditional
- Product code
- KPQ
- Device class
- 2
- Regulation number
- 892.5840
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Palo Alto, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Ximatron Digital Imaging (Ximavision), V 7.5.51 with Service Pack (SP), Oncology Informati recall (Z-0213-2008) | Varian Medical Systems Inc | 2007-11-08 |