Rapid ASPECTS (v3)

FDA 510(k) K232156 · Ischemaview, Inc.

Substantially Equivalent

510(k) numberK232156

Submission

Device name
Rapid ASPECTS (v3)
Applicant
Ischemaview, Inc.
Golden, CO, US
Received
July 20, 2023
Decision date
January 19, 2024
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
POK – Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
Device class
Class II (moderate risk)
Regulation
21 CFR 892.2060
Specialty
Radiology

Assist users in characterizing lesions identified on acquired medical images

Other 510(k)s with product code POK

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K253884Koios DS (3.8)POK · Traditional Koios Medical, Inc.07/02/2026SE
K261519Sonio SuspectPOK · Special Sonio06/04/2026SE
K254161Automated Aortic Stenosis Software (AutoAS)POK · Traditional GE Medical Systems Ultrasound & Primary Care…03/27/2026SE
K251769RevealAI-LungPOK · Traditional Precision Medical Ventures, Inc. Dba Revealdx01/30/2026SE
K252294Fetal EchoScan (v1.2)POK · Traditional Brightheart12/08/2025SE
K250221StrokeSENS ASPECTS Software ApplicationPOK · Traditional Circle Cardiovascular Imaging, Inc.07/01/2025SE
K251071Fetal EchoScan (v1.1)POK · Special Brightheart05/02/2025SE
K243614Sonio SuspectPOK · Traditional Sonio02/21/2025SE
K243294Brainomix 360 e-ASPECTSPOK · Traditional Brainomix Limited02/14/2025SE
K242130Koios DSPOK · Traditional Koios Medical, Inc.11/15/2024SE

More from Koios Medical, Inc.

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K261085Rapid Vessel Occlusion (Rapid VO)QAS · Traditional 07/13/2026SE
K251987Rapid Aortic MeasurementsQIH · Traditional 09/23/2025SE
K251533Rapid Obstructive Hydrocephalus, Rapid OHQAS · Traditional 09/04/2025SE
K252526Rapid DeltaFuseLLZ · Traditional 08/26/2025SE
K251151Rapid CTA 360QAS · Traditional 07/16/2025SE
K243378Rapid MLSQIH · Traditional 05/28/2025SE
K243350Rapid Neuro3DQIH · Traditional 01/22/2025SE
K233582RapidLLZ · Traditional 04/22/2024SE
K233512Rapid (6.0)QIH · Special 01/16/2024SE
K232436Rapid SDHQAS · Traditional 10/25/2023SE

Questions and answers

When was Rapid ASPECTS (v3) cleared by the FDA?

Rapid ASPECTS (v3) (K232156) received a 510(k) decision of Substantially Equivalent on January 19, 2024, 183 days after the submission was received.

What is the product code of K232156?

The FDA product code is POK – Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer, a Class II (moderate risk) device regulated under 21 CFR 892.2060.