Nuclear Medical Systems, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Nuclear Medical Systems, Inc.” (first 1977, latest 1982), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 77 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 |
|---|---|---|---|
| JFH | Acid Phosphatase (Prostatic), Tartrate Inhibited | 1 | 1 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 1 | 1 |
| JHX | Fluorometric Method, Cpk Or Isoenzymes | 1 | 1 |
| JKC | Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate) | 1 | 1 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 1 | 1 |
Review panels
Most recent Nuclear Medical Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K821145 | I-DHEA-SULFATE RIA KIT 125 | JKC | 1982-05-14 | 23 |
| K791735 | PAP RIA KIT | JFH | 1979-11-15 | 77 |
| K791582 | CARDIO CK-B RIA KIT | JHX | 1979-11-15 | 92 |
| K780679 | B-HCG-RIA | JHI | 1978-06-14 | 51 |
| K771378 | NEO TSH-RIA KIT | JLW | 1977-10-18 | 90 |
Recalls
openFDA lists no recalls under a recalling firm named Nuclear Medical Systems, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Nuclear Medical Laboratories, Inc. (24 510(k)s)
- Nuclear Diagnostics, Inc. (23 510(k)s)
- Nuclear Data, Inc. (7 510(k)s)
- Nuclear Ent. , Ltd. (3 510(k)s)
- Nuclear Cardiology Systems, Inc. (2 510(k)s)
- Nuclear Data Systems (2 510(k)s)
- Nuclear Assoc., Div. Inovision LP (1 510(k)s)
- Nuclear Associates (1 510(k)s)
- Nuclear Concepts, Inc. (1 510(k)s)
- Nuclear Diagnostics AB (1 510(k)s)
- Nuclear Medicine, Inc. (1 510(k)s)
- Nuclear Pacific, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Nuclear Medical Systems, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Nuclear Medical Systems, Inc.” (first 1977, latest 1982), across 5 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Nuclear Medical Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Nuclear Medical Systems, Inc. is 77 days.
Which FDA product codes appear under Nuclear Medical Systems, Inc.?
The most frequent FDA product codes under this applicant name are JFH (Acid Phosphatase (Prostatic), Tartrate Inhibited, 1); JHI (Visual, Pregnancy Hcg, Prescription Use, 1); JHX (Fluorometric Method, Cpk Or Isoenzymes, 1).
Next steps
- See all 5 Nuclear Medical Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JFH, Nuclear Medical Systems, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.