IMAGYN 125 I SEED, MODEL IS 125
FDA 510(k) clearance K982421 · decided 1998-07-31
Clearance details
- K-number
- K982421
- Device name
- IMAGYN 125 I SEED, MODEL IS 125
- Applicant
- International Isotopes, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-07-13
- Decision date
- 1998-07-31
- Days to decision
- 18 days
- Clearance type
- Special
- Product code
- IWG
- Device class
- 2
- Regulation number
- 892.5730
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Denton, TX, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch International Isotopes
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| BRACHYTHERAPY SOURCE DEVICE, MODEL 9011 (K081066) | Medi-Physics, Inc., Dba GE Healthcare | 2008-05-05 |
| GOLD SEADS (K834027) | Radiation Safety & Nuclear Products, Inc. | 1983-12-27 |
Recalls involving this device
No recalls on record reference this clearance.