Source-Ray, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Source-Ray, Inc.” (first 2003, latest 2016), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 72 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 | 1 | 394 |
| 2016 | 1 | 40 |
| 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 | 6 | 6 |
| KPR | System, X-Ray, Stationary | 2 | 2 |
Review panels
- Radiology (8)
Most recent Source-Ray, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K163063 | UC-5000 Mobile X-Ray | IZL | 2016-12-12 | 40 |
| K133959 | PODIATRY X-RAY SYSTEM | KPR | 2015-01-22 | 394 |
| K090655 | PORTABLE X-RAY SYSTEM, MODEL POWERMAX 1260 | IZL | 2009-07-14 | 125 |
| K071392 | PXS-810, PODIATRY X-RAY SYSTEM | KPR | 2007-08-03 | 77 |
| K062472 | OPTIONAL REMOTE CONTROL, MODEL RC-115, FOR PORTABLE X-RAY SYSTEM, MODEL SR-115 | IZL | 2006-10-31 | 68 |
| K052001 | MODEL SR-115 PORTABLE X-RAY SYSTEM | IZL | 2005-08-11 | 17 |
| K043062 | MODEL SR-130-D PORTABLE DIGITAL X-RAY SYSTEM | IZL | 2004-12-13 | 38 |
| K030494 | SR-130 | IZL | 2003-05-20 | 90 |
Recalls
openFDA lists no recalls under a recalling firm named Source-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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Source-Ray, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Source-Ray, Inc.” (first 2003, latest 2016), across 2 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 Source-Ray, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Source-Ray, Inc. is 72 days.
Which FDA product codes appear under Source-Ray, Inc.?
The most frequent FDA product codes under this applicant name are IZL (System, X-Ray, Mobile, 6); KPR (System, X-Ray, Stationary, 2).
Next steps
- See all 8 Source-Ray, Inc. clearances with predicates and recalls
- Run predicate analysis for product code IZL, Source-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.