Rapid ASPECTS

Q: When was Rapid ASPECTS cleared by the FDA?

Rapid ASPECTS (K200760) received a 510(k) decision of Substantially Equivalent on June 26, 2020, 94 days after the submission was received.

Q: What is the product code of K200760?

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.

FDA 510(k) K200760 · Ischemaview, Inc.

Substantially Equivalent

510(k) numberK200760

Submission

Device name: Rapid ASPECTS
Applicant: Ischemaview, Inc.
Golden, CO, US
Received: March 24, 2020
Decision date: June 26, 2020
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

510(k)	Device	Applicant	Decision
K253884	Koios DS (3.8)POK · Traditional	Koios Medical, Inc.	07/02/2026SE
K261519	Sonio SuspectPOK · Special	Sonio	06/04/2026SE
K254161	Automated Aortic Stenosis Software (AutoAS)POK · Traditional	GE Medical Systems Ultrasound & Primary Care…	03/27/2026SE
K251769	RevealAI-LungPOK · Traditional	Precision Medical Ventures, Inc. Dba Revealdx	01/30/2026SE
K252294	Fetal EchoScan (v1.2)POK · Traditional	Brightheart	12/08/2025SE
K250221	StrokeSENS ASPECTS Software ApplicationPOK · Traditional	Circle Cardiovascular Imaging, Inc.	07/01/2025SE
K251071	Fetal EchoScan (v1.1)POK · Special	Brightheart	05/02/2025SE
K243614	Sonio SuspectPOK · Traditional	Sonio	02/21/2025SE
K243294	Brainomix 360 e-ASPECTSPOK · Traditional	Brainomix Limited	02/14/2025SE
K242130	Koios DSPOK · Traditional	Koios Medical, Inc.	11/15/2024SE

More from Koios Medical, Inc.

510(k)	Device	Decision
K261085	Rapid Vessel Occlusion (Rapid VO)QAS · Traditional	07/13/2026SE
K251987	Rapid Aortic MeasurementsQIH · Traditional	09/23/2025SE
K251533	Rapid Obstructive Hydrocephalus, Rapid OHQAS · Traditional	09/04/2025SE
K252526	Rapid DeltaFuseLLZ · Traditional	08/26/2025SE
K251151	Rapid CTA 360QAS · Traditional	07/16/2025SE
K243378	Rapid MLSQIH · Traditional	05/28/2025SE
K243350	Rapid Neuro3DQIH · Traditional	01/22/2025SE
K233582	RapidLLZ · Traditional	04/22/2024SE
K232156	Rapid ASPECTS (v3)POK · Traditional	01/19/2024SE
K233512	Rapid (6.0)QIH · Special	01/16/2024SE

Questions and answers

When was Rapid ASPECTS cleared by the FDA?

Rapid ASPECTS (K200760) received a 510(k) decision of Substantially Equivalent on June 26, 2020, 94 days after the submission was received.

What is the product code of K200760?

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.