PALLADIUM SEED MODEL 100
FDA 510(k) clearance K852542 · decided 1986-01-14
Clearance details
- K-number
- K852542
- Device name
- PALLADIUM SEED MODEL 100
- Applicant
- Nuclear Medicine, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-06-14
- Decision date
- 1986-01-14
- Days to decision
- 214 days
- Clearance type
- Traditional
- Product code
- IWI
- Device class
- 2
- Regulation number
- 892.5730
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Atlanta, GA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Nuclear Medicine
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 |
|---|---|---|
| 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 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.