Comet Ltd. C/O Radiology Resources, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Comet Ltd. C/O Radiology Resources, Inc.” (first 1987, latest 1991), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 64 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 |
|---|---|---|---|
| ITY | Assembly, Tube Housing, X-Ray, Diagnostic | 3 | 3 |
| IZH | System, X-Ray, Mammographic | 1 | 1 |
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | 1 | 1 |
Review panels
- Radiology (5)
Most recent Comet Ltd. C/O Radiology Resources, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K912338 | TUBE HOUSING ASSEMBLIES | ITY | 1991-08-07 | 75 |
| K911695 | VARIOUS X-RAY TUBES | ITY | 1991-06-19 | 64 |
| K910842 | DI2000/HS-45-150 X-RAY TUBE INSERT | ITY | 1991-03-06 | 7 |
| K901997 | X-RAY TUBE HOUSING ASSEMBLY, VARIOUS MODELS | IZH | 1990-06-06 | 35 |
| K864749 | TELAMAT | JAA | 1987-02-10 | 67 |
Recalls
openFDA lists no recalls under a recalling firm named Comet Ltd. C/O Radiology Resources, 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.
- Comet North America, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Comet Ltd. C/O Radiology Resources, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Comet Ltd. C/O Radiology Resources, Inc.” (first 1987, latest 1991), across 3 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 Comet Ltd. C/O Radiology Resources, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Comet Ltd. C/O Radiology Resources, Inc. is 64 days.
Which FDA product codes appear under Comet Ltd. C/O Radiology Resources, Inc.?
The most frequent FDA product codes under this applicant name are ITY (Assembly, Tube Housing, X-Ray, Diagnostic, 3); IZH (System, X-Ray, Mammographic, 1); JAA (System, X-Ray, Fluoroscopic, Image-Intensified, 1).
Next steps
- See all 5 Comet Ltd. C/O Radiology Resources, Inc. clearances with predicates and recalls
- Run predicate analysis for product code ITY, Comet Ltd. C/O Radiology Resources, 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.