Ischemaview

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
30112056753014269683ISCHEMAVIEW, INC.1N2026-01-011120 Washington Ave Ste 200, #108 Golden CO US 80401

GUDID Contact Samples

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDIDProductPhoneEmail
B7615511Rapid - Rapid System Update303-704-3374rosa@ischemaview.com
B761R5701Rapid - Rapid System Update303-704-3374rosa@ischemaview.com

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1757711283826437K252526Rapid DeltaFuseLLZ2025-08-26
1757711478587005K251987Rapid Aortic MeasurementsQIH2025-09-23
1757711752111669K251533Rapid Obstructive Hydrocephalus, Rapid OHQAS2025-09-04
1757711418434257K251151Rapid CTA 360QAS2025-07-16
1757711284084557K243378Rapid MLSQIH2025-05-28
1757711059452259K243350Rapid Neuro3DQIH2025-01-22
1757711508981567K233582RapidLLZ2024-04-22
1757712058550924K233512Rapid (6.0)QIH2024-01-16
1757711963707863K232436Rapid SDHQAS2023-10-25
1757711735828685K232156Rapid ASPECTS (v3)POK2024-01-19
1757711380791377K230074Rapid Aneurysm Triage and NotificationQFM2023-07-27
1757711171691258K223396Rapid RV/LVQIH2023-02-01
1757711141199013K222884Rapid NCCT StrokeQAS2023-03-02
1757711617934665K221456Rapid ICHQAS2022-09-12
1757711229342841K221248Rapid LVOQAS2022-05-31
1757711744880281K220499Rapid PE Triage and Notification (PETN)QAS2022-05-17
1757711410772456K213165RapidLLZ2022-02-08
1757711529278061K200941Rapid LVOQAS2020-07-09
1757711566952601K200760Rapid ASPECTSPOK2020-06-26
1757711476651329K193087Rapid ICHQAS2020-03-31
1757711500696587K182130iSchemaView RAPIDLLZ2018-12-27
1757711383168800K172477iSchemaView RAPIDLLZ2018-04-19
1757711579013533K171534SurgicalPreviewPZO2017-11-08
1757711181322399K121447ISCHEMA VIEW RAPIDLLZ2013-10-04

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
QAS92025-09-04
LLZ62025-08-26
QIH52025-09-23
POK22024-01-19
QFM12023-07-27
PZO12017-11-08

PMN

Rapid

2024-04-22

Ischemaview, Inc.

Rapid

2022-02-08

Ischemaview, Inc.

GUDID