Data / Medical devices / United States / Surgical Radiation Products LLC
Surgical Radiation Products LLC: FDA-registered device maker in North Palm Beach, FL, United States, 1 510(k) clearance
Surgical Radiation Products LLC is registered with the FDA (registration 3027080417) in North Palm Beach, FL, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated July 18, 2018. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3027080417
- Address
- 700 US Highway One Suite D, North Palm Beach, FL, United States, 33408
- Owner or operator
- Surgical Radiation Products LLC (10087712)
- Roles
- Specification developer
- First device listed
- March 29, 2023
- Registered through
- 2026
- Brand names listed
- Accusyte 3D Fiducial Marking System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accelerator, Linear, Medical | IYE | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 18, 2018 | K180027 | ACCUSYTE 3D Fiducial Marker | IYE | Substantially Equivalent | Radiation Products, LLC | accessdata.fda.gov |
Compare with other makers
Updated July 18, 2018. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.