Continental X-Ray Corp.: FDA filings under this applicant name
FDA lists 27 510(k) clearances under the applicant name “Continental X-Ray Corp.” (first 1988, latest 1997), across 13 product codes in 1 review panel. Median 510(k) review time under this name: 104 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 |
|---|---|---|---|
| IZO | Generator, High-Voltage, X-Ray, Diagnostic | 5 | 5 |
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | 4 | 4 |
| IZZ | Table, Radiographic, Non-Tilting, Powered | 3 | 3 |
| IXQ | Table, Radiographic, Stationary Top | 2 | 2 |
| IZF | System, X-Ray, Tomographic | 2 | 2 |
| IZH | System, X-Ray, Mammographic | 2 | 2 |
| KPR | System, X-Ray, Stationary | 2 | 2 |
| KXJ | Table, Radiologic | 2 | 2 |
| IXL | Device, Spot-Film | 1 | 1 |
| IXR | Table, Radiographic, Tilting | 1 | 1 |
Plus 3 more product codes.
Review panels
- Radiology (27)
Most recent Continental X-Ray Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K972442 | CEILING MOUNTED LATERAL POSITIONER, MODEL NO. 6896.002 | JAA | 1997-09-11 | 73 |
| K962140 | ICT-2000, INTEGRATED C-ARM/TABLE MULTIPURPOSE RADIOGRAPHIC/FLUOROSCOPIC POSITIONING SYSTEM MODEL NO. 6896.300 | JAA | 1996-07-25 | 52 |
| K961690 | CARDIOARC SERIES: POSITIONER C-ARM MODELS NO. 6896.001 AND 6896.105 | JAA | 1996-06-27 | 57 |
| K954581 | ARC SERIES | IZI | 1995-12-21 | 80 |
| K950571 | LINEAR FR TOMOGRAPHIC SYSTEM: 0MT 8000, MODEL NO. 6681.270 | IZF | 1995-03-31 | 59 |
| K942175 | LINEAR TOMOGRAPHIC SYSTEM: PMT 6000 | IZF | 1994-08-17 | 105 |
| K942100 | MODEL TM EP HIGH VOLTAGE GENERATOR | IZO | 1994-06-07 | 42 |
| K934686 | MOLYBDENUM/RHODIUM FILTERS | IZO | 1994-05-26 | 239 |
| K931724 | ELECTROPHYSIOLOGY (EP) TABLE EP 2000 SERIES | KXJ | 1993-06-14 | 82 |
| K925934 | WALL BUCKY HOLDERS LT. & RT. HAND, & CENTER MOUNT | IXY | 1993-03-04 | 104 |
17 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Continental X-Ray 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.
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.
- Continental Medical Laboratories, Inc. (8 510(k)s)
- Continental Optical Imports (2 510(k)s)
- Continental Soft Lens, Inc. (2 510(k)s)
- Continental Dental Ceramics, Inc. (1 510(k)s)
- Continental Dental Ceramics, Inc. (Dba Continental (1 510(k)s)
- Continental Dental Laboratory (1 510(k)s)
- Continental Products, Inc. (1 510(k)s)
- Continental Scale Corp. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Continental X-Ray Corp.?
FDA lists 27 510(k) clearances under the applicant name “Continental X-Ray Corp.” (first 1988, latest 1997), across 13 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 Continental X-Ray Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Continental X-Ray Corp. is 104 days.
Which FDA product codes appear under Continental X-Ray Corp.?
The most frequent FDA product codes under this applicant name are IZO (Generator, High-Voltage, X-Ray, Diagnostic, 5); JAA (System, X-Ray, Fluoroscopic, Image-Intensified, 4); IZZ (Table, Radiographic, Non-Tilting, Powered, 3).
Next steps
- See all 27 Continental X-Ray Corp. clearances with predicates and recalls
- Run predicate analysis for product code IZO, Continental X-Ray 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.