FDA applicant
Stentor, Inc.
FDA records 3 decisions for Stentor, Inc. (San Leandro, CA) from 1999 to 2004: 3 510(k) clearances. Most are in product codes LLZ (System, Image Processing, Radiological) and LMD (System, Digital Image Communications…). Its devices cite 6 predicates, 0 of them its own earlier devices. 7 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Stentor, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Stentor, Inc. since 2007.
Recalls per year
1in 2011
Class I Class II/III not classified
Planning a device like Stentor, 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) ReportOther applicant names beginning “Stentor”
FDA records each applicant name separately; these may or may not be the same firm.