FDA applicant
Anatomage, Inc.
FDA records 6 decisions for Anatomage, Inc. (San Jose, CA) from 2007 to 2018: 6 510(k) clearances. All are in product code LLZ (System, Image Processing, Radiological). Its devices cite 10 predicates, 3 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Anatomage, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2018
2007high 1 (2007) · low 0 (2008)2026
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Anatomage, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report