Data / Medical devices / United States / Ischemaview, Inc.

Ischemaview, Inc.: FDA-registered device maker in Golden, CO, United States, 24 510(k) clearances

Name: Ischemaview, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Ischemaview, Inc. is registered with the FDA (registration 3011205675) in Golden, CO, United States. It lists 6 device types. The FDA files 24 510(k) clearances under its listings, the newest dated September 23, 2025. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this one Watch Ischemaview, Inc.

FDA registration number: 3011205675
FEI number: 3014269683
Address: 1120 Washington Ave Ste 200, #108, Golden, CO, United States, 80401
Owner or operator: iSchemaView, Inc. (10047732)
Roles: Manufacturer
First device listed: October 24, 2014
Registered through: 2026
Brand names listed: Lumina 3D, Lumina 3D by RapidAI, Lumina 3D by iSchemaView, RAPID, Rapid, Rapid ANRT, Rapid ASPECTS, Rapid AngioFlow and more

Devices it lists

Device	Product code	Class	Role	Source
Automated Radiological Image Processing Software	QIH	2	Manufacturer	accessdata.fda.gov
Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer	POK	2	Manufacturer	accessdata.fda.gov
Radiological Computer-Assisted Prioritization Software For Lesions	QFM	2	Manufacturer	accessdata.fda.gov
Radiological Computer-Assisted Triage And Notification Software	QAS	2	Manufacturer	accessdata.fda.gov
Software For Visualization Of Vascular Anatomy And Intravascular Devices	PZO	2	Manufacturer	accessdata.fda.gov
System, Image Processing, Radiological	LLZ	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
September 23, 2025	K251987	Rapid Aortic Measurements	QIH	Substantially Equivalent	Ischemaview, Inc.	accessdata.fda.gov
September 4, 2025	K251533	Rapid Obstructive Hydrocephalus, Rapid OH	QAS	Substantially Equivalent	Ischemaview, Inc.	accessdata.fda.gov
August 26, 2025	K252526	Rapid DeltaFuse	LLZ	Substantially Equivalent	Ischemaview, Inc.	accessdata.fda.gov
July 16, 2025	K251151	Rapid CTA 360	QAS	Substantially Equivalent	Ischemaview	accessdata.fda.gov
May 28, 2025	K243378	Rapid MLS	QIH	Substantially Equivalent	Ischemaview, Inc.	accessdata.fda.gov
January 22, 2025	K243350	Rapid Neuro3D	QIH	Substantially Equivalent	Ischemaview, Inc.	accessdata.fda.gov
April 22, 2024	K233582	Rapid	LLZ	Substantially Equivalent	Ischemaview, Inc.	accessdata.fda.gov
January 19, 2024	K232156	Rapid ASPECTS (v3)	POK	Substantially Equivalent	Ischemaview, Inc.	accessdata.fda.gov
January 16, 2024	K233512	Rapid (6.0)	QIH	Substantially Equivalent	Ischemaview, Inc.	accessdata.fda.gov
October 25, 2023	K232436	Rapid SDH	QAS	Substantially Equivalent	Ischemaview, Inc.	accessdata.fda.gov
July 27, 2023	K230074	Rapid Aneurysm Triage and Notification	QFM	Substantially Equivalent	Ischemaview, Inc.	accessdata.fda.gov
March 2, 2023	K222884	Rapid NCCT Stroke	QAS	Substantially Equivalent	Ischemaview, Inc.	accessdata.fda.gov
February 1, 2023	K223396	Rapid RV/LV	QIH	Substantially Equivalent	Ischemaview, Inc.	accessdata.fda.gov
September 12, 2022	K221456	Rapid ICH	QAS	Substantially Equivalent	Ischemaview, Inc.	accessdata.fda.gov
May 31, 2022	K221248	Rapid LVO	QAS	Substantially Equivalent	Ischemaview, Inc.	accessdata.fda.gov
May 17, 2022	K220499	Rapid PE Triage and Notification (PETN)	QAS	Substantially Equivalent	Ischemaview, Inc.	accessdata.fda.gov
February 8, 2022	K213165	Rapid	LLZ	Substantially Equivalent	Ischemaview, Inc.	accessdata.fda.gov
July 9, 2020	K200941	Rapid LVO	QAS	Substantially Equivalent	Ischemaview, Inc.	accessdata.fda.gov
June 26, 2020	K200760	Rapid ASPECTS	POK	Substantially Equivalent	Ischemaview, Inc.	accessdata.fda.gov
March 31, 2020	K193087	Rapid ICH	QAS	Substantially Equivalent	Ischemaview Incorporated	accessdata.fda.gov
December 27, 2018	K182130	iSchemaView RAPID	LLZ	Substantially Equivalent	Ischemaview, Inc.	accessdata.fda.gov
April 19, 2018	K172477	iSchemaView RAPID	LLZ	Substantially Equivalent	Ischemaview, Inc.	accessdata.fda.gov
November 8, 2017	K171534	SurgicalPreview	PZO	Substantially Equivalent	Endo Vantage, LLC	accessdata.fda.gov
October 4, 2013	K121447	ISCHEMA VIEW RAPID	LLZ	Substantially Equivalent	Ischemaview, Inc.	accessdata.fda.gov

Compare with other makers

Updated September 23, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.