Control-X, Inc.: FDA clearances and approvals
Control-X, Inc. has 9 FDA 510(k) clearances (first 1991, latest 1995), across 5 product codes in 1 review panel. Median 510(k) review time: 157 days.
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 |
| IXY | Holder, Radiographic Cassette, Wall-Mounted | 1 | 1 |
| IZF | System, X-Ray, Tomographic | 1 | 1 |
| IZZ | Table, Radiographic, Non-Tilting, Powered | 1 | 1 |
| KPR | System, X-Ray, Stationary | 1 | 1 |
Review panels
- Radiology (9)
Most recent Control-X, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K952265 | MILESTONW 350/450/550HF, PCX N350/450/550HF, TOP-X 350/450/550HF RADIOGRAPHIC X-RAY GENERATOR | IZO | 1995-07-06 | 52 |
| K920347 | TOP-X 650HF RADIOGRAPHIC X-RAY | KPR | 1993-05-17 | 479 |
| K924445 | BA-4 WALL BUCKY AND BA-42 TILTING WALL BUCKY | IXY | 1993-02-19 | 171 |
| K920351 | PCX 650HF RADIOGRAPHIC X-RAY | IZO | 1993-02-12 | 385 |
| K920349 | PCX 1050HF RADIOGRAPHIC X-RAY GENERATOR | IZO | 1993-02-12 | 385 |
| K924444 | B-4 FOUR-WAY RADIOGRAPHIC TABLE | IZZ | 1993-02-05 | 157 |
| K924443 | RS-3 UNIVERSAL RADIOGRAPHIC WORKING PLACE | IZF | 1993-02-05 | 157 |
| K913577 | MILESTONE MS 325 RADIOGRAPHIC X-RAY GENERATOR | IZO | 1991-11-05 | 85 |
| K913578 | MILESTONE MS 525 RADIOGRAPHIC X-RAY GENERATOR | IZO | 1991-11-01 | 81 |
Recalls
openFDA lists no recalls under a recalling firm named Control-X, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Control-X, Inc. have?
Control-X, Inc. has 9 FDA 510(k) clearances (first 1991, latest 1995), across 5 product codes in 1 review panel.
How long does FDA take to clear Control-X, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Control-X, Inc.'s cleared 510(k)s is 157 days.
What devices does Control-X, Inc. make?
Its most frequent FDA product codes are IZO (Generator, High-Voltage, X-Ray, Diagnostic, 5); IXY (Holder, Radiographic Cassette, Wall-Mounted, 1); IZF (System, X-Ray, Tomographic, 1).
Has Control-X, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Control-X, Inc. Related entities may recall under other names.
Next steps
- See all 9 Control-X, Inc. clearances with predicates and recalls
- Run predicate analysis for product code IZO, Control-X, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.