IR-192 IMPLANT, MODIFICATION
FDA 510(k) clearance K915253 · decided 1992-02-27
Clearance details
- K-number
- K915253
- Device name
- IR-192 IMPLANT, MODIFICATION
- Applicant
- Omnitron Intl., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-11-18
- Decision date
- 1992-02-27
- Days to decision
- 101 days
- Clearance type
- Traditional
- Product code
- IWA
- Device class
- 2
- Regulation number
- 892.5730
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Lajke Charles, LA, 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 |
|---|---|---|
| CESIUM-137 MICROSEED SOURCE TRAIN ASSEMBLY/SHIELD (K894409) | Amersham Corp. | 1989-09-29 |
| IR-192 IMPLANT (K874895) | Rads S.L., Inc. | 1988-02-25 |
| IRIDIUM SEEDS (K850382) | Radiation Safety & Nuclear Products, Inc. | 1985-08-15 |
| IR-192 IMPLANT (K844248) | Rads S.L., Inc. | 1985-04-10 |
| WIRE CUTTERS, BRACHYTHERAPY-TABLE TOP & HAND HELD (K850726) | Syncor Intl. Corp. | 1985-03-26 |
| IRIDIUM 192 WIRES (K850163) | Syncor Intl. Corp. | 1985-03-26 |
| IRIDIUM 192 WIRES & PINS (K771878) | Cis Radiopharmaceuticals, Inc. | 1977-10-27 |
Recalls involving this device
No recalls on record reference this clearance.