BRACHYTHERAPY SOURCE DEVICE, MODEL 9011
FDA 510(k) clearance K081066 · decided 2008-05-05
Clearance details
- K-number
- K081066
- Device name
- BRACHYTHERAPY SOURCE DEVICE, MODEL 9011
- Applicant
- Medi-Physics, Inc., Dba GE Healthcare
- Decision
- Substantially Equivalent
- Date received
- 2008-04-15
- Decision date
- 2008-05-05
- Days to decision
- 20 days
- Clearance type
- Special
- Product code
- IWG
- Device class
- 2
- Regulation number
- 892.5730
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Princeton, NJ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| IMAGYN 125 I SEED, MODEL IS 125 (K982421) | International Isotopes, Inc. | 1998-07-31 |
| GOLD SEADS (K834027) | Radiation Safety & Nuclear Products, Inc. | 1983-12-27 |
Recalls involving this device
No recalls on record reference this clearance.