NORTH AMERICAN SCIENTIFIC(NASI)PD-103 RADIONUCLIDE BRACHYTHERAPY SOURCE-MODEL MED3633
FDA 510(k) clearance K973363 · decided 1998-07-02
Clearance details
- K-number
- K973363
- Device name
- NORTH AMERICAN SCIENTIFIC(NASI)PD-103 RADIONUCLIDE BRACHYTHERAPY SOURCE-MODEL MED3633
- Applicant
- Ml Strategies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-09-08
- Decision date
- 1998-07-02
- Days to decision
- 297 days
- Clearance type
- Traditional
- Product code
- IWI
- Device class
- 2
- Regulation number
- 892.5730
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Boston, MA, 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 |
|---|---|---|
| I-125 RAPID STRAND (K940632) | Medi-Physics Inc. Dba Nycomed Amersham Imaging | 1994-09-02 |
| RADIOACTIVE IODINE-125 SOURCES (K912170) | Best Industries | 1991-08-09 |
| 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.