FDA.reportPublic FDA data

Overjet Iris Intelligent Imaging System

Primary DI
00860013927820
Brand
Overjet Iris Intelligent Imaging System
Company
Overjet, Inc.
Model
v1
Published
2026-05-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K253930000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K253930000Overjet Iris Intelligent Imaging SystemOverjet, Inc.2026-04-10QIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860013927820PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860013927820008600139278208600139278200860013927820

GMDN Terms#

Term, Definition table
TermDefinition
Radiological PACS softwareAn individual software application intended to be installed on a central server as part of a picture archiving and communication system (PACS) to allow storage, retrieval, analysis, and management of radiological images.

Regulatory Flags#

DUNS number
116916753
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860005586394Overjet CBCT Assistv12025-12-12
00860005586301Overjet Dental Assistv12024-11-12
00860005586318Overjet Caries Assistv12024-11-12
00860005586325Overjet Calculus Assistv12024-11-12
00860005586332Overjet Periapical Radiolucency Assistv12024-11-12
00860005586349Overjet DI Systemv12024-11-12
00860005586356Overjet Charting Assistv12024-11-12
00860005586363Overjet Caries Assist-Pediatricv12024-11-12
00860005586370Overjet Image Enhancement Assistv12024-11-12

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Primary DI, Brand, Company table
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B720BX360ECTA1420e-CTABRAINOMIX LIMITEDQIH2026-02-03
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08800290041767EA2-11AVSAMSUNG MEDISON CO., LTD.QIH2026-01-28
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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
00198953113516LOGIQGE Ultrasound Korea Ltd.QIH2026-01-21