FDA.reportPublic FDA data

Overjet DI System

Primary DI
00860005586349
Brand
Overjet DI System
Company
Overjet, Inc.
Model
v1
Published
2024-11-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
LMDSystem, Digital Image Communications, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LMDSystem, Digital Image Communications, RadiologicalRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860005586349PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860005586349008600055863498600055863490860005586349

GMDN Terms#

Term, Definition table
TermDefinition
Radiological PACS-dedicated management softwareA software program dedicated for installation on a central server as part of a picture archiving and communication system (PACS) to allow storage, retrieval, analysis, and management of a broad range of radiological images throughout the healthcare system. As a PACS-dedicated software, it is not primarily intended for diagnosis support, triage, or treatment planning. It does not incorporate adaptive/dynamic machine learning (ML) models.

Regulatory Flags#

DUNS number
116916753
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860013927820Overjet Iris Intelligent Imaging Systemv12026-05-13
00860005586301Overjet Dental Assistv12024-11-12
00860005586318Overjet Caries Assistv12024-11-12
00860005586325Overjet Calculus Assistv12024-11-12
00860005586332Overjet Periapical Radiolucency Assistv12024-11-12
00860005586356Overjet Charting Assistv12024-11-12
00860005586363Overjet Caries Assist-Pediatricv12024-11-12
00860005586370Overjet Image Enhancement Assistv12024-11-12
00860005586394Overjet CBCT Assistv12025-12-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04056481144616Quip EyeBrainlab SELMD2026-08-25
04056481145804Brainlab Origin ORBrainlab SELMD2026-08-21
00850054590183interWORKSAvreo IncLMD2026-08-03
00850054590176interWORKSAvreo IncLMD2026-07-29
04056481147099Buzz O.R. ComputeBrainlab SELMD2026-07-09
00850054590169interWORKSAvreo IncLMD2026-07-08
B214CORELABV100CORELabmedimaps group SALMD2026-06-29
00850025268417Vitrea Advanced VisualizationCanon Medical Informatics, Inc.LMD2026-06-05
30009336010630Nissha Medical TechnologiesGRAPHIC CONTROLS ACQUISITION CORPLMD2026-06-01
00850025268424Vitrea Advanced VisualizationCanon Medical Informatics, Inc.LMD2026-05-12
08800026700890Medit AuraVueMedit Corp.LMD2026-05-11
00810111225663X-ray AppTreace Medical Concepts, Inc.LMD2026-05-01
00628105001212Vitrea ReadCanon Medical Informatics A/SLMD2026-04-27
05415334057258Eonis 32”Barco NVLMD2026-04-13
00628105001229Vitrea ReadCanon Medical Informatics A/SLMD2026-04-03
EPIS960010EpisurfViewEpisurf Operations ABLMD2026-03-17
07290018052402aiOSAIDOC MEDICAL LTDLMD2026-03-08
00850025268400Vitrea Advanced VisualizationCanon Medical Informatics, Inc.LMD2026-02-27
04260483290312MammoScapeMeVis Medical Solutions AGLMD2026-02-16
00884838074798IntelliSpace PACS AnywherePhilips Medical Systems Nederland B.V.LMD2026-02-07
00850025268394Vitrea Advanced VisualizationCanon Medical Informatics, Inc.LMD2026-01-21
05060634690072EchoGoULTROMICS LIMITEDLMD2026-01-14
00850054590152interWORKSAvreo IncLMD2025-12-08
05415334053045Eonis 3DBarco NVLMD2025-12-01
00628105001205Vitrea ReadCanon Medical Informatics A/SLMD2025-11-21
00850013331086SentiARSentiar, Inc.LMD2025-11-21
00850013331093SentiARSentiar, Inc.LMD2025-11-21
00850013331109SentiARSentiar, Inc.LMD2025-11-21
00850061871374IMAGE DIAGNOSTICS INCIMAGE DIAGNOSTICS, INC.LMD2025-11-18
00850054590145interWORKSAvreo IncLMD2025-11-14