FDA.reportPublic FDA data

qER-Quant

Primary DI
00860005118137
Brand
qER-Quant
Company
QURE.AI TECHNOLOGIES PRIVATE LIMITED
Model
1.0.0
Device description
The qER-Quant device is intended for automatic labeling, visualization and quantification of segmentable brain structures from a set of Non-Contrast head CT (NCCT) images. The software is intended to automate the current manual process of identifying, labeling and quantifying the volume of segmentable brain structures identified on NCCT images.
Published
2022-05-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QIHAutomated Radiological Image Processing Software

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QIHAutomated Radiological Image Processing SoftwareRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K211222000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211222000qER-QuantQure.Ai Technologies2021-07-30QIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860005118137PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860005118137008600051181378600051181370860005118137

GMDN Terms#

Term, Definition table
TermDefinition
Radiology DICOM image processing application softwareA software application intended to facilitate management, distribution, and/or viewing of radiological digital imaging and communications in medicine (DICOM) image data; it is not intended for pathological image interpretation (i.e., not intended to detect and localize suspected abnormalities). It may be intended to facilitate image management (e.g., viewing, communication, printing, recording/ disc burning) and/or image manipulation and quantification (e.g., non-interpretive graphical overlays).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(262)347-9734support@qure.ai

Regulatory Flags#

DUNS number
860393884
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850057636024qXR-LN1.0.02024-06-24
00850057636000qXR-CTR1.0.02023-10-10
00850057636017qXR-PTX-PE1.0.02023-10-10
00860005118144qXR-BT1.0.02022-05-31
00860005118106qER2.0.02020-12-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860008194435Cycle ClarityCycle Clarity, LLCQIH2026-05-21
00754016387128ANDIImeka Solutions IncQIH2026-05-14
00860013927820Overjet Iris Intelligent Imaging SystemOverjet, Inc.QIH2026-05-13
08437021722093ADAS 3DADAS3D MEDICAL S.L.QIH2026-05-12
00198715128956AngiowaveAngioWave Imaging, LLCQIH2026-05-09
07613336231098Opulus Lymphoma PrecisionRoche Molecular Systems, Inc.QIH2026-05-08
08437021468045QP-Brain®QUIBIM SOCIEDAD LIMITADA.QIH2026-05-06
B720BX360ECTA1430e-CTABRAINOMIX LIMITEDQIH2026-05-06
00860010264638EZRA PLEXO SOFTWAREEzra Ai, Inc.QIH2026-05-05
08437023642047NemoScanSOFTWARE NEMOTEC SLQIH2026-04-23
00860000171229SubtleSYNTHSubtle Medical, Inc.QIH2026-04-09
00860000171243SubtleHD(MR)Subtle Medical, Inc.QIH2026-04-09
08800124700136SwiftMRAIRS Medical Inc.QIH2026-04-01
G703AIORTAPLAN0AiORTA - PlanVitaa Medical Solutions Inc.QIH2026-03-30
B720BX360ECTA1210Brainomix 360 e-CTABRAINOMIX LIMITEDQIH2026-03-30
08800066200626MEDIHUB PROSTATEJLK, Inc.QIH2026-03-25
00884838122154EchoNavigatorPhilips Medical Systems Nederland B.V.QIH2026-03-25
10603295562108VELYS Hip NavigationDEPUY ORTHOPAEDICS, INC.QIH2026-03-24
08800130400303Neurophet AQUA AD PlusNEUROPHET Inc.QIH2026-02-24
G762AISAPCARDIOV10AISAP Cardio V1.0AISAP LTDQIH2026-02-18
B720BX360ECTA1420e-CTABRAINOMIX LIMITEDQIH2026-02-03
08800290027471EV2-12SAMSUNG MEDISON CO., LTD.QIH2026-01-28
08800290041767EA2-11AVSAMSUNG MEDISON CO., LTD.QIH2026-01-28
08800290041811EA2-11ARSAMSUNG MEDISON CO., LTD.QIH2026-01-28
08800290042481PA2-9SSAMSUNG MEDISON CO., LTD.QIH2026-01-28
08800290042726CA2-13MSAMSUNG MEDISON CO., LTD.QIH2026-01-28
08800290065473EV2-12SAMSUNG MEDISON CO., LTD.QIH2026-01-28
00195278932358Spectral Bone MarrowGE Medical Systems, L.L.C.QIH2026-01-26
00198953113554LOGIQGE Ultrasound Korea Ltd.QIH2026-01-26
00198953113493LOGIQGE Ultrasound Korea Ltd.QIH2026-01-21