Nuclear Data, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Nuclear Data, Inc.” (first 1984, latest 1989), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 112 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 |
|---|---|---|---|
| KGI | Densitometer, Bone | 3 | 3 |
| IZD | Probe, Uptake, Nuclear | 2 | 2 |
| JJJ | Counter (Beta, Gamma) For Clinical Use | 1 | 1 |
| LMB | Device, Digital Image Storage, Radiological | 1 | 1 |
Review panels
- Radiology (6)
- Clinical Chemistry (1)
Most recent Nuclear Data, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K891466 | ACCUSPEC THYROID UPTAKE SYSTEM | IZD | 1989-06-06 | 83 |
| K881383 | ND1100 BONE DENSITY SCANNER | KGI | 1989-05-22 | 416 |
| K844835 | ND2100 SPINE SCANNER | KGI | 1985-04-18 | 127 |
| K844766 | ND1100 BONE DENSITY SCANNER | KGI | 1985-04-16 | 130 |
| K843349 | ND3100 VIDEO IMAGER | LMB | 1984-12-17 | 112 |
| K841440 | ND62T THYROID UPTAKE SYSTEM | IZD | 1984-06-05 | 60 |
| K841352 | ND1200 RIA COUNTER | JJJ | 1984-05-02 | 30 |
Recalls
openFDA lists no recalls under a recalling firm named Nuclear Data, 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 Medical Systems, Inc. (5 510(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 Data, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Nuclear Data, Inc.” (first 1984, latest 1989), across 4 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Nuclear Data, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Nuclear Data, Inc. is 112 days.
Which FDA product codes appear under Nuclear Data, Inc.?
The most frequent FDA product codes under this applicant name are KGI (Densitometer, Bone, 3); IZD (Probe, Uptake, Nuclear, 2); JJJ (Counter (Beta, Gamma) For Clinical Use, 1).
Next steps
- See all 7 Nuclear Data, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KGI, Nuclear Data, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.