RADIOACTIVE IODINE-125 SOURCES
FDA 510(k) clearance K912170 · decided 1991-08-09
Clearance details
- K-number
- K912170
- Device name
- RADIOACTIVE IODINE-125 SOURCES
- Applicant
- Best Industries
- Decision
- Substantially Equivalent
- Date received
- 1991-05-16
- Decision date
- 1991-08-09
- Days to decision
- 85 days
- Clearance type
- Traditional
- Product code
- IWI
- Device class
- 2
- Regulation number
- 892.5730
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Springfield, VA, 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 |
|---|---|---|
| NORTH AMERICAN SCIENTIFIC(NASI)PD-103 RADIONUCLIDE BRACHYTHERAPY SOURCE-MODEL MED3633 (K973363) | Ml Strategies, Inc. | 1998-07-02 |
| I-125 RAPID STRAND (K940632) | Medi-Physics Inc. Dba Nycomed Amersham Imaging | 1994-09-02 |
| CESIUM 137 SOURCE, MODEL CSM-40 (K882449) | Cis-Us, Inc. | 1989-04-14 |
| MODIFIED PALLADIUM SEED MODEL 100 (K874787) | Theragenics Corp. | 1987-12-22 |
| PALLADIUM SEED MODEL 100 (K852542) | Nuclear Medicine, Inc. | 1986-01-14 |
Recalls involving this device
No recalls on record reference this clearance.