FDA applicant
Computerized Medical Systems, Inc.
FDA records 23 decisions for Computerized Medical Systems, Inc. (St. Louis, MO) from 1985 to 2011: 23 510(k) clearances. Most are in product codes MUJ (System, Planning, Radiation Therapy Treatment) and IYE (Accelerator, Linear, Medical). Its devices cite 33 predicates, 6 of them its own earlier devices. 40 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Computerized Medical Systems, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2011
2026 so far, outlined.
Recalls per year
1in 2016
Class I Class II/III not classified
Planning a device like Computerized 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) ReportOther applicant names beginning “Computerized”
FDA records each applicant name separately; these may or may not be the same firm.