510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Ischemaview, Inc.

Golden, CO, US

ISCHEMAVIEW, INC. appears in FDA device records in Golden, CO. FDA records list 23 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
23
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 23 510(k) clearances for Ischemaview, Inc. between 2013 and 2026. The busiest year on record is 2025, with 6. The most recent is 2026, with 1.

Clearances by year, as a table
510(k) clearance decisions for Ischemaview, Inc., by decision year
YearClearances
20131
20182
20202
20224
20234
20243
20256
20261
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K261085Rapid Vessel Occlusion (Rapid VO)QASSubstantially Equivalent
K251987Rapid Aortic MeasurementsQIHSubstantially Equivalent
K251533Rapid Obstructive Hydrocephalus, Rapid OHQASSubstantially Equivalent
K252526Rapid DeltaFuseLLZSubstantially Equivalent
K251151Rapid CTA 360QASSubstantially Equivalent
K243378Rapid MLSQIHSubstantially Equivalent
K243350Rapid Neuro3DQIHSubstantially Equivalent
K233582RapidLLZSubstantially Equivalent
K232156Rapid ASPECTS (v3)POKSubstantially Equivalent
K233512Rapid (6.0)QIHSubstantially Equivalent
K232436Rapid SDHQASSubstantially Equivalent
K230074Rapid Aneurysm Triage and NotificationQFMSubstantially Equivalent
K222884Rapid NCCT StrokeQASSubstantially Equivalent
K223396Rapid RV/LVQIHSubstantially Equivalent
K221456Rapid ICHQASSubstantially Equivalent
K221248Rapid LVOQASSubstantially Equivalent
K220499Rapid PE Triage and Notification (PETN)QASSubstantially Equivalent
K213165RapidLLZSubstantially Equivalent
K200941Rapid LVOQASSubstantially Equivalent
K200760Rapid ASPECTSPOKSubstantially Equivalent
K182130iSchemaView RAPIDLLZSubstantially Equivalent
K172477iSchemaView RAPIDLLZSubstantially Equivalent
K121447ISCHEMA VIEW RAPIDLLZSubstantially Equivalent

Registered establishments

FDA registered establishments for Ischemaview, Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30112056753014269683ISCHEMAVIEW, INC.1120 Washington Ave, Golden, CO 80401 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain