Data / Medical devices / United States / Candelis, Inc.
Candelis, Inc.: FDA-registered device maker in Beverly Hills, CA, United States, 4 510(k) clearances
Candelis, Inc. is registered with the FDA (registration 3005919188) in Beverly Hills, CA, United States. It lists 1 device type. The FDA files 4 510(k) clearances under its listings, the newest dated July 23, 2026. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3005919188
- Address
- 9903 South Santa Monica Blvd, #2101, Beverly Hills, CA, United States, 90212
- Owner or operator
- Candelis, Inc. (9092139)
- Roles
- Manufacturer
- First device listed
- January 11, 2011
- Registered through
- 2026
- Brand names listed
- ASTRA, IMAGEGRID, IMAGEGRID RADIOLOGY VIEWER SYSTEM, ImageGrid StreamVue
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 |
|---|---|---|---|---|---|---|
| July 23, 2026 | K262143 | ImageGrid StreamVue | LLZ | Substantially Equivalent | Candelis, Inc. | accessdata.fda.gov |
| September 15, 2011 | K111694 | ASTRA | LLZ | Substantially Equivalent | Candelis, Inc. | accessdata.fda.gov |
| October 8, 2009 | K092949 | IMAGEGRID RADIOLOGY VIEWER SYSTEM | LLZ | Substantially Equivalent | Candelis, Inc. | accessdata.fda.gov |
| February 22, 2008 | K080333 | IMAGEGRID | LLZ | Substantially Equivalent | Candelis, Inc. | accessdata.fda.gov |
Compare with other makers
Updated July 23, 2026. 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.