FDA applicant
Ischemaview, Inc.
FDA records 26 decisions for Ischemaview, Inc. (Golden, CO) from 2013 to 2026: 26 510(k) clearances. Most are in product codes QAS (Radiological Computer-Assisted Triage And…) and LLZ (System, Image Processing, Radiological). Since 2016 its 510(k)s took a median of 106 days from receipt to decision, against 116 for FDA’s reviews in the same codes and years. Its devices cite 26 predicates, 18 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Ischemaview Incorporated”, “Ischemaview”, “iSchemaview”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Ischemaview, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
6in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2013.
Planning a device like Ischemaview, 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