Cgr Medical Corp.: FDA filings under this applicant name
FDA lists 20 510(k) clearances under the applicant name “Cgr Medical Corp.” (first 1978, latest 1984), across 10 product codes in 1 review panel. Median 510(k) review time under this name: 42 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 |
|---|---|---|---|
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 4 | 4 |
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | 3 | 3 |
| IZO | Generator, High-Voltage, X-Ray, Diagnostic | 2 | 2 |
| JAK | System, X-Ray, Tomography, Computed | 2 | 2 |
| ITY | Assembly, Tube Housing, X-Ray, Diagnostic | 1 | 1 |
| IXR | Table, Radiographic, Tilting | 1 | 1 |
| IYE | Accelerator, Linear, Medical | 1 | 1 |
| IZI | System, X-Ray, Angiographic | 1 | 1 |
| IZP | Programmer, Changer, Film/Cassette, Radiographic | 1 | 1 |
Plus 1 more product codes.
Review panels
- Radiology (16)
Most recent Cgr Medical Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K843926 | PRESTILIX 1690 | IXR | 1984-12-17 | 51 |
| K843235 | STENOSCOP | JAA | 1984-11-08 | 84 |
| K843985 | SUSPENSION 7 | — | 1984-11-05 | 25 |
| K841649 | MAXIMAX - 4 | IZP | 1984-06-05 | 46 |
| K833223 | SONEL 3000A | IYO | 1984-05-09 | 244 |
| K834306 | PHASIX-HIGH FREQUENCY GENERATOR | ITY | 1983-12-29 | 55 |
| K833941 | ORION | IYE | 1983-12-29 | 44 |
| K833846 | PROCESS 100 ST | IZO | 1983-12-16 | 92 |
| K837465 | ALCYON ROTATIONAL COBALT THERAPY | — | 1983-06-28 | 56 |
| K837412 | SATURNE I LINEAR ACCELERATOR | — | 1983-06-28 | 68 |
10 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Cgr Medical Corp..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Cgr Medical Corp.?
FDA lists 20 510(k) clearances under the applicant name “Cgr Medical Corp.” (first 1978, latest 1984), across 10 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 Cgr Medical Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cgr Medical Corp. is 42 days.
Which FDA product codes appear under Cgr Medical Corp.?
The most frequent FDA product codes under this applicant name are IYO (System, Imaging, Pulsed Echo, Ultrasonic, 4); JAA (System, X-Ray, Fluoroscopic, Image-Intensified, 3); IZO (Generator, High-Voltage, X-Ray, Diagnostic, 2).
Next steps
- See all 20 Cgr Medical Corp. clearances with predicates and recalls
- Run predicate analysis for product code IYO, Cgr Medical Corp.'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.