General X-Ray, Inc.: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “General X-Ray, Inc.” (first 1978, latest 1980), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 18 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 |
|---|---|---|---|
| IZL | System, X-Ray, Mobile | 11 | 11 |
| EHB | Collimator, X-Ray | 1 | 1 |
| KPQ | System, Simulation, Radiation Therapy | 1 | 1 |
Plus 1 more product codes.
Review panels
- Radiology (13)
Most recent General X-Ray, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K800998 | ATLAS-S X-RAY SYSTEM W/KETROMAT GEN. | — | 1980-05-28 | 33 |
| K790451 | X-RAY UNITS, GX-101, UCIS-510 AND GX-111 | IZL | 1979-03-28 | 23 |
| K790512 | PORTABLE X-RAY UNIT | IZL | 1979-03-26 | 10 |
| K790511 | MOBILE X-RAY UNIT | IZL | 1979-03-26 | 10 |
| K790443 | PORTABLE X-RAY UNIT | IZL | 1979-03-26 | 19 |
| K790393 | PORTABLE X-RAY UNIT, MATRIX S GX-101 | IZL | 1979-03-26 | 28 |
| K790392 | 510 CARBINETTE X-RAY UNIT | IZL | 1979-03-26 | 28 |
| K781976 | MOBILE X-RAY UNIT | IZL | 1978-12-04 | 7 |
| K781975 | MOBILE CARRIER | IZL | 1978-12-04 | 7 |
| K781675 | X-RAY COLLIMATOR | EHB | 1978-12-04 | 66 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named General X-Ray, 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.
- General Electric Co. (254 510(k)s)
- General Diagnostics (39 510(k)s)
- General Electric Medical Systems Information Techn (33 510(k)s)
- General Biometrics, Inc. (23 510(k)s)
- General Medical Co. (15 510(k)s)
- General Surgical Innovations (14 510(k)s)
- General Devices (13 510(k)s)
- General Physiotherapy, Inc. (9 510(k)s)
- General Medical Merate S.P.A (7 510(k)s)
- General Theraphysical, Inc. (7 510(k)s)
- General Atomics (6 510(k)s)
- General Electric Medical Systems (6 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under General X-Ray, Inc.?
FDA lists 14 510(k) clearances under the applicant name “General X-Ray, Inc.” (first 1978, latest 1980), across 4 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 General X-Ray, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name General X-Ray, Inc. is 18 days.
Which FDA product codes appear under General X-Ray, Inc.?
The most frequent FDA product codes under this applicant name are IZL (System, X-Ray, Mobile, 11); EHB (Collimator, X-Ray, 1); KPQ (System, Simulation, Radiation Therapy, 1).
Next steps
- See all 14 General X-Ray, Inc. clearances with predicates and recalls
- Run predicate analysis for product code IZL, General X-Ray, 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.