Medi-Physics Inc. Dba Nycomed Amersham Imaging: FDA clearances and approvals
Medi-Physics Inc. Dba Nycomed Amersham Imaging has 9 FDA 510(k) clearances (first 1981, latest 2001), across 6 product codes in 1 review panel. Median 510(k) review time: 53 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KXK | Source, Brachytherapy, Radionuclide | 4 | 4 |
| IWI | Source, Isotope, Sealed, Gold, Titanium, Platinum | 1 | 1 |
| IWJ | System, Applicator, Radionuclide, Manual | 1 | 1 |
| IWR | Holder, Syringe, Lead | 1 | 1 |
| IYT | System, Rebreathing, Radionuclide | 1 | 1 |
| KPY | Shield, Protective, Personnel | 1 | 1 |
Review panels
- Radiology (9)
Most recent Medi-Physics Inc. Dba Nycomed Amersham Imaging 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K010821 | ECHOSEED/IODINE-125 SEEDS, MODEL 6733 | KXK | 2001-04-11 | 23 |
| K940632 | I-125 RAPID STRAND | IWI | 1994-09-02 | 200 |
| K921961 | SDMO APPLICATOR CODE: ASN.8236 | IWJ | 1992-07-01 | 65 |
| K915156 | I-125 SEEDS CODE: 6702 | KXK | 1992-01-06 | 53 |
| K914281 | I-125 SEEDS, CODE: 6711 | KXK | 1991-11-22 | 59 |
| K914268 | I-125 SEEDS IN CARRIER, CODE: 6720 | KXK | 1991-11-22 | 60 |
| K811688 | TUNGSTEN SYRINGE SHIELD | IWR | 1981-07-02 | 17 |
| K811677 | KRYPTON CART | KPY | 1981-07-02 | 17 |
| K811118 | KRYPTON MASKS & TUBING | IYT | 1981-06-02 | 39 |
Recalls
openFDA lists no recalls under a recalling firm named Medi-Physics Inc. Dba Nycomed Amersham Imaging.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Medi-Physics Inc. Dba Nycomed Amersham Imaging have?
Medi-Physics Inc. Dba Nycomed Amersham Imaging has 9 FDA 510(k) clearances (first 1981, latest 2001), across 6 product codes in 1 review panel.
How long does FDA take to clear Medi-Physics Inc. Dba Nycomed Amersham Imaging's 510(k)s?
The median time from FDA receipt to decision across Medi-Physics Inc. Dba Nycomed Amersham Imaging's cleared 510(k)s is 53 days.
What devices does Medi-Physics Inc. Dba Nycomed Amersham Imaging make?
Its most frequent FDA product codes are KXK (Source, Brachytherapy, Radionuclide, 4); IWI (Source, Isotope, Sealed, Gold, Titanium, Platinum, 1); IWJ (System, Applicator, Radionuclide, Manual, 1).
Has Medi-Physics Inc. Dba Nycomed Amersham Imaging had device recalls?
openFDA lists no recalls under a recalling firm name matching Medi-Physics Inc. Dba Nycomed Amersham Imaging. Related entities may recall under other names.
Next steps
- See all 9 Medi-Physics Inc. Dba Nycomed Amersham Imaging clearances with predicates and recalls
- Run predicate analysis for product code KXK, Medi-Physics Inc. Dba Nycomed Amersham Imaging's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.