Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011205675

FEI Number

3014269683

Entity Name

ISCHEMAVIEW, INC.

City/State/Country

Golden, CO, US

Establishment Address

1120 Washington Ave, Ste 200, #108, Golden, CO 80401, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

iSchemaView, Inc. (Owner Number: 10047732)

Owner / Operator Contact Address

1120 Washington Ave, Suite 200, Rm 108, Golden, CO 80401, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K172477

PMA Number

N/A

All Registered Proprietary Names

Rapid ICH SurgicalPreview Rapid MLS Rapid LVO Rapid Neuro 3D Lumina 3D by RapidAI Rapid N3D Lumina 3D Lumina 3D by iSchemaView iSchemaView Lumina 3D Rapid RVLV Rapid ICH Rapid Rapid LVO Rapid Aortic Measurement Rapid C-Arm CTP Rapid Rapid AngioFlow Rapid CTA 360 Rapid LMVO Rapid VO+ Rapid NCCT Stroke Rapid ANRT Rapid ASPECTS Rapid ASPECTS Rapid SDH Rapid OH RAPID

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QAS	Radiological Computer-Assisted Triage And Notification Software	Radiology	Class 2	892.2080	2020-07-06
PZO	Software For Visualization Of Vascular Anatomy And Intravascular Devices	Radiology	Class 2	892.2050	2020-07-06
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2026-05-27
QAS	Radiological Computer-Assisted Triage And Notification Software	Radiology	Class 2	892.2080	2022-11-28
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2025-01-24
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2023-09-07
QAS	Radiological Computer-Assisted Triage And Notification Software	Radiology	Class 2	892.2080	2022-11-28
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2022-05-23
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2022-05-23
QAS	Radiological Computer-Assisted Triage And Notification Software	Radiology	Class 2	892.2080	2020-09-11
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2026-05-27
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2024-04-29
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2024-04-29
QAS	Radiological Computer-Assisted Triage And Notification Software	Radiology	Class 2	892.2080	2025-07-21
QAS	Radiological Computer-Assisted Triage And Notification Software	Radiology	Class 2	892.2080	2023-04-10
QFM	Radiological Computer-Assisted Prioritization Software For Lesions	Radiology	Class 2	892.2080	2023-09-07
POK	Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer	Radiology	Class 2	892.2060	2020-07-06
POK	Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer	Radiology	Class 2	892.2060	2024-04-29
QAS	Radiological Computer-Assisted Triage And Notification Software	Radiology	Class 2	892.2080	2024-01-04
QAS	Radiological Computer-Assisted Triage And Notification Software	Radiology	Class 2	892.2080	2026-05-27
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2018-08-20

Official Correspondent

James Rosa

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

iSchemaView, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K220709	Aidoc Medical , Ltd.	BriefCase	2022-10-07
K250160	Mentice Spain S.L.	ANKYRAS	2025-05-06
K242270	Orthofix Srl	OrthoNext Platform System	2024-12-19
K261713	FUJIFILM Healthcare Americas Corporation	Synapse PACS (7.6.0)	2026-06-18
K243647	FUJIFILM Healthcare Americas Corporation	Synapse PACS (7.5)	2025-06-30

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0012-2022	GE Healthcare, LLC	2	Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system
Z-0023-2016	GE Healthcare	2	Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.
Z-0030-2026	CHANGE HEALTHCARE CANADA COMPANY	2	Change Healthcare Radiology Solutions software version 14.2.2
Z-0032-2012	Philips Healthcare Inc.	2	MDC PACS - release R2.3 SP1 . Phillips Healthcare Andover, Massachusetts A software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD).
Z-0033-2007	AGFA Corp.	2	IMPAX 5.2 Systems with CAD Capability (Computer Assisted Diagnosis)

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011205675. Last updated year: 2026. Please use registration number 3011205675 when referencing this establishment in official correspondence.