FDA applicant
Tomtec Imaging Systems GmbH
FDA records 23 decisions for Tomtec Imaging Systems GmbH (Unterschleissheim, DE) from 1995 to 2022: 23 510(k) clearances. Most are in product codes LLZ (System, Image Processing, Radiological) and IYO (System, Imaging, Pulsed Echo, Ultrasonic). Its devices cite 42 predicates, 31 of them its own earlier devices. 2 recalls are linked to its devices.
FDA’s records also spell it “Tomtec Imaging Systems, Inc.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Tomtec Imaging Systems GmbH’s devices, and how often a recall has named them.
FDA decisions per year
1in 2022
2026 so far, outlined.
Recalls per year
1in 2019
Class I Class II/III not classified
Planning a device like Tomtec Imaging Systems GmbH’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 “Tomtec”
FDA records each applicant name separately; these may or may not be the same firm.