Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medi-Physics Inc. Dba Nycomed Amersham Imaging · Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
53 daysmedian FDA review time
200 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K010821 | ECHOSEED/IODINE-125 SEEDS, MODEL 6733 | Medi-Physics Inc. Dba Nycomed Amersham Imaging | 2001-04-11 | 23 | 0 |
| K940632 | I-125 RAPID STRAND | Medi-Physics Inc. Dba Nycomed Amersham Imaging | 1994-09-02 | 200 | 0 |
| K921961 | SDMO APPLICATOR CODE: ASN.8236 | Medi-Physics Inc. Dba Nycomed Amersham Imaging | 1992-07-01 | 65 | 0 |
| K915156 | I-125 SEEDS CODE: 6702 | Medi-Physics Inc. Dba Nycomed Amersham Imaging | 1992-01-06 | 53 | 0 |
| K914281 | I-125 SEEDS, CODE: 6711 | Medi-Physics Inc. Dba Nycomed Amersham Imaging | 1991-11-22 | 59 | 0 |
| K914268 | I-125 SEEDS IN CARRIER, CODE: 6720 | Medi-Physics Inc. Dba Nycomed Amersham Imaging | 1991-11-22 | 60 | 0 |
| K811688 | TUNGSTEN SYRINGE SHIELD | Medi-Physics Inc. Dba Nycomed Amersham Imaging | 1981-07-02 | 17 | 0 |
| K811677 | KRYPTON CART | Medi-Physics Inc. Dba Nycomed Amersham Imaging | 1981-07-02 | 17 | 0 |
| K811118 | KRYPTON MASKS & TUBING | Medi-Physics Inc. Dba Nycomed Amersham Imaging | 1981-06-02 | 39 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda