THERATRON ELITE
FDA 510(k) clearance K983917 · decided 1998-12-04
Clearance details
- K-number
- K983917
- Device name
- THERATRON ELITE
- Applicant
- Theratronics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-11-04
- Decision date
- 1998-12-04
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- IWB
- Device class
- 2
- Regulation number
- 892.5750
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Kanata, Ontario, Canada, CA
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Theratron Elite 80 Cobalt Radiotherapy recall (Z-1183-06) | MDS Canada Inc. DBA MDS Nordion | 2006-06-27 |
| Theratron Elite 100 Cobalt Radiotherapy recall (Z-1184-06) | MDS Canada Inc. DBA MDS Nordion | 2006-06-27 |