Data / Medical devices / United States / Anatomage, Inc.
Anatomage, Inc.: FDA-registered device maker in Santa Clara, CA, United States, 4 510(k) clearances
Anatomage, Inc. is registered with the FDA (registration 3008272529) in Santa Clara, CA, United States. It lists 1 device type. The FDA files 4 510(k) clearances under its listings, the newest dated September 21, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008272529
- Address
- 3350 Scott Blvd # 29, Santa Clara, CA, United States, 95054
- Owner or operator
- Anatomage, Inc. (10031379)
- Roles
- Manufacturer
- First device listed
- March 28, 2014
- Registered through
- 2026
- Brand names listed
- CephSimulation, Cloud 3D, InVivoDental, Table, TxStudio
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 21, 2018 | K181926 | InVivo Web Viewer | LLZ | Substantially Equivalent | Anatomage, Inc. | accessdata.fda.gov |
| January 4, 2017 | K161270 | CephSimulation | LLZ | Substantially Equivalent | Anatomage, Inc. | accessdata.fda.gov |
| March 7, 2014 | K140093 | TABLE | LLZ | Substantially Equivalent | Anatomage, Inc. | accessdata.fda.gov |
| February 1, 2013 | K123519 | INVIVO DENTAL | LLZ | Substantially Equivalent | Anatomage, Inc. | accessdata.fda.gov |
Compare with other makers
Updated September 21, 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.