Data / Medical devices / United States / StatRad, LLC
StatRad, LLC: FDA-registered device maker in San Diego, CA, United States, 1 510(k) clearance
StatRad, LLC is registered with the FDA (registration 3008008144) in San Diego, CA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated September 15, 2009. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3008008144
- Address
- 13280 Evening Creek Dr S Ste 110, San Diego, CA, United States, 92128
- Owner or operator
- StatRad, LLC (10030388)
- Roles
- Manufacturer
- First device listed
- September 25, 2009
- Registered through
- 2027
- Brand names listed
- StatPACS
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Image Processing, Radiological | LLZ | 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 |
|---|---|---|---|---|---|---|
| September 15, 2009 | K092134 | STAT PACS PICTURE ARCHIVING & COMMUNICATION SYSTEM (PACS) | LLZ | Substantially Equivalent | Statrad, LLC | accessdata.fda.gov |
Compare with other makers
Updated September 15, 2009. 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.