# Ischemaview, Inc.

- Location (FDA's records): Golden, CO
- FDA decisions: 26 (2013–2026): 26 510(k) clearances
- Names in FDA's records: Ischemaview, Inc. (23); Ischemaview Incorporated (1); Ischemaview (1); iSchemaview (1)
- Product codes: QAS (11), LLZ (6), QIH (6), POK (2), QFM (1)
- 510(k) review time since 2016: median 106 days, against 116 for FDA's reviews in the same codes and years (14 of 24 faster)
- Predicates its devices cite: 26 (18 its own); citations of its devices by later devices: 37 (18 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Aidoc Medical, Ltd.: 2 (https://510kreport.com/company/aidoc-medical)
- Quantitative Insights, Inc.: 1 (https://510kreport.com/company/quantitative-insights)
- Viz. Ai, Inc.: 1 (https://510kreport.com/company/viz-ai)
- Avicenna.Ai: 1 (https://510kreport.com/company/avicenna-ai)
- Olea Medical: 1 (https://510kreport.com/company/olea-medical)
- Qure.Ai Technologies: 1 (https://510kreport.com/company/qure-ai-technologies)
- Imbio, LLC: 1 (https://510kreport.com/company/imbio)

## Firms that cite its devices most
- Brainomix Limited: 6 (https://510kreport.com/company/brainomix)
- JLK, Inc.: 3 (https://510kreport.com/company/jlk)
- Yiwei Medical Technology Co., Ltd.: 1 (https://510kreport.com/company/yiwei-medical-technology)
- Harrison-AI Medical Pty, Ltd.: 1 (https://510kreport.com/company/harrison-ai-medical)
- ArteryFlow Technology Co., Ltd.: 1 (https://510kreport.com/company/arteryflow-technology)
- Nico-Lab B.V.: 1 (https://510kreport.com/company/nico-lab)
- Methinks Software, S.L: 1 (https://510kreport.com/company/methinks-software-s-l)
- Apollo Medical Imaging Technology Pty., Ltd.: 1 (https://510kreport.com/company/apollo-medical-imaging-technology)

## Its most-cited devices
- K121447: Ischema View Rapid (2013), cited by 9
- K222884: Rapid NCCT Stroke (2023), cited by 4
- K200760: Rapid ASPECTS (2020), cited by 3
- K213165: Rapid (2022), cited by 3
- K172477: iSchemaView RAPID (2018), cited by 3
- K233582: Rapid (2024), cited by 2

## Recent decisions
- K262301: Rapid ICH (v4.0) (Oct 9, 2026)
- K261368: Rapid Platform (R6.7) (Sep 21, 2026)
- K261085: Rapid Vessel Occlusion (Rapid VO) (Jul 13, 2026)
- K251987: Rapid Aortic Measurements (Sep 23, 2025)
- K251533: Rapid Obstructive Hydrocephalus, Rapid OH (Sep 4, 2025)
- K252526: Rapid DeltaFuse (Aug 26, 2025)
- K251151: Rapid CTA 360 (Jul 16, 2025)
- K243378: Rapid MLS (May 28, 2025)

Source page: https://510kreport.com/company/ischemaview