Data / Medical devices / United States / Carina Medical LLC
Carina Medical LLC: FDA-registered device maker in Ashburn, VA, United States, 2 510(k) clearances
Carina Medical LLC is registered with the FDA (registration 3022719374) in Ashburn, VA, United States. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated May 13, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3022719374
- Address
- 42822 Ravenglass Dr, Ashburn, VA, United States, 20148
- Owner or operator
- Carina Medical LLC (10085173)
- Roles
- Manufacturer
- First device listed
- May 16, 2022
- Registered through
- 2026
- Brand names listed
- INTContour, INTDose
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accelerator, Linear, Medical | IYE | 2 | Manufacturer | accessdata.fda.gov |
| Radiological Image Processing Software For Radiation Therapy | QKB | 2 | Manufacturer | accessdata.fda.gov |
| System, Planning, Radiation Therapy Treatment | MUJ | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| May 13, 2022 | K213137 | INTDose | IYE | Substantially Equivalent | Carina Medical, LLC | accessdata.fda.gov |
| April 8, 2022 | K212274 | INT Contour | MUJ | Substantially Equivalent | Carina Medical, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Radiological Image Processing Software For Radiation Therapy
- All makers of System, Planning, Radiation Therapy Treatment
- All makers of Accelerator, Linear, Medical
Updated May 13, 2022. 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.