Source-Ray, Inc.
Ronkonkoma, NY, US
Source-Ray, Inc. appears in FDA device records in Ronkonkoma, NY. FDA records list 8 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 8 510(k) clearances for Source-Ray, Inc. between 2003 and 2016. The busiest year on record is 2003, with 1. The most recent is 2016, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2003 | 1 |
| 2004 | 1 |
| 2005 | 1 |
| 2006 | 1 |
| 2007 | 1 |
| 2009 | 1 |
| 2015 | 1 |
| 2016 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K163063 | UC-5000 Mobile X-Ray | IZL | Substantially Equivalent | |
| K133959 | PODIATRY X-RAY SYSTEM | KPR | Substantially Equivalent | |
| K090655 | PORTABLE X-RAY SYSTEM, MODEL POWERMAX 1260 | IZL | Substantially Equivalent | |
| K071392 | PXS-810, PODIATRY X-RAY SYSTEM | KPR | Substantially Equivalent | |
| K062472 | OPTIONAL REMOTE CONTROL, MODEL RC-115, FOR PORTABLE X-RAY SYSTEM, MODEL SR-115 | IZL | Substantially Equivalent | |
| K052001 | MODEL SR-115 PORTABLE X-RAY SYSTEM | IZL | Substantially Equivalent | |
| K043062 | MODEL SR-130-D PORTABLE DIGITAL X-RAY SYSTEM | IZL | Substantially Equivalent | |
| K030494 | SR-130 | IZL | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3004606964 | 3004606964 | Source-Ray, Inc. | 50 Fleetwood Ct, Ronkonkoma, NY 11779 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain