Xerox Medical Systems: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Xerox Medical Systems” (first 1979, latest 1985), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 71 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 |
|---|---|---|---|
| IZH | System, X-Ray, Mammographic | 2 | 2 |
| EAP | Unit, X-Ray, Intraoral | 1 | 1 |
| IXK | System, Imaging, X-Ray, Electrostatic | 1 | 1 |
| KPX | Changer, Radiographic Film/Cassette | 1 | 1 |
Review panels
- Radiology (5)
Most recent Xerox Medical Systems 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K853459 | XERORADIOGRAPHY LIQUID TONER IMAGING SYSTEM | IXK | 1985-10-30 | 75 |
| K833243 | MAMMOGRAPHIC S-RAY SYSTEM | IZH | 1983-10-28 | 71 |
| K832733 | XEROX 120 SYS MAMMOGRAPHIC X-RAY | IZH | 1983-09-29 | 41 |
| K812024 | XEROX 128 CASSETTE CHANGER | KPX | 1981-08-13 | 24 |
| K791014 | DENTAL XERORADIOGRAPHY | EAP | 1979-09-04 | 95 |
Recalls
openFDA lists no recalls under a recalling firm named Xerox Medical Systems.
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.
- Xerox Corp. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Xerox Medical Systems?
FDA lists 5 510(k) clearances under the applicant name “Xerox Medical Systems” (first 1979, latest 1985), 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 Xerox Medical Systems?
The median time from FDA receipt to decision across 510(k)s cleared under the name Xerox Medical Systems is 71 days.
Which FDA product codes appear under Xerox Medical Systems?
The most frequent FDA product codes under this applicant name are IZH (System, X-Ray, Mammographic, 2); EAP (Unit, X-Ray, Intraoral, 1); IXK (System, Imaging, X-Ray, Electrostatic, 1).
Next steps
- See all 5 Xerox Medical Systems clearances with predicates and recalls
- Run predicate analysis for product code IZH, Xerox Medical Systems'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.