FDA applicant
Impac Medical Systems, Inc.
FDA records 13 decisions for Impac Medical Systems, Inc. (Mountain View, CA) from 1991 to 2015: 13 510(k) clearances. Most are in product codes IYE (Accelerator, Linear, Medical) and MUJ (System, Planning, Radiation Therapy Treatment). Its devices cite 20 predicates, 9 of them its own earlier devices. 41 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Impac Medical Systems, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2015
2026 so far, outlined.
Recalls per year
1in 2023
Class I Class II/III not classified
Planning a device like Impac Medical Systems, 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