FDA applicant
Vital Images, Inc.
FDA records 41 decisions for Vital Images, Inc. (Minnetonka, MN) from 1995 to 2018: 41 510(k) clearances. Most are in product codes LLZ (System, Image Processing, Radiological) and JAK (System, X-Ray, Tomography, Computed). Since 2016 its 510(k)s took a median of 53 days from receipt to decision, against 106 for FDA’s reviews in the same codes and years. Its devices cite 66 predicates, 35 of them its own earlier devices. 10 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Vital Images, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2018
2026 so far, outlined.
Recalls per year
4in 2013
Class I Class II/III not classified
Planning a device like Vital Images, 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 “Vital”
FDA records each applicant name separately; these may or may not be the same firm.