FDA.reportPublic FDA data

Discovery

Primary DI
00840682143523
Brand
Discovery
Company
GE Medical Systems, L.L.C.
Model
MI
Device description
PET DMI Image System Asm, No Detectors Installed, Common Weld Gantry, Manufacturing Make
Published
2019-03-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
JAKSystem, x-ray, tomography, computed
KPSSystem, tomography, computed, emission

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JAKSystem, X-Ray, Tomography, ComputedRadiology2
KPSSystem, Tomography, Computed, EmissionRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K161574000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161574000Discovery MIGe Medical Systems, LLC2016-08-11KPS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840682143523PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840682143523008406821435238406821435230840682143523

GMDN Terms#

Term, Definition table
TermDefinition
PET systemAn assembly of devices comprising a diagnostic, positron emission tomography (PET) imaging system used to detect, record, quantify and analyse 511 kilo-electronvolt (keV) photon emission patterns resulting from annihilation reactions produced during the decay of positron emitting radiopharmaceuticals. It produces three-dimensional (3-D) tomographic digital cross-sectional physiological images representing distribution patterns of positron emitting radiopharmaceuticals ingested by, or injected into the patient. It typically uses lead collimators and specialized software for image reconstruction allowing mapping of metabolic patterns and rates associated with targeted physiological processes.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
144879404
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00198953085950PhotonovaSpectra5590000-502026-05-11
00195278789365Critical Care Suite2.158331262023-10-19
00195278460271RevolutionApex Elite5590000-232022-12-16
00195278471277Revolution CTES with Apex edition5826588-X2022-12-16
00195278502179RevolutionApex Plus5590000-252022-12-16
00195278486813NASIGNA Hero2022-02-11
00195278472083NA6265300-202021-12-31
00195278098603DiscoveryMI2020-10-20
00195278023643NASIGNA Architect2020-07-20
00198953255315NA9265300-32026-07-08
00840682138796Revolution160mm Detector Upgrade2018-01-11
00198953081839NA6265300-602026-04-02
00198953081877NA6265300-622026-04-02
00840682120784Flashpad HD25302017-07-28
00840682120807Flashpad HD35432017-07-28
00840682103053DiscoveryPETCT 6102016-08-01
00840682143974O560 to 610 Upgrade5607000-22018-12-05
00840682145749OptimaXR240amx HD Upgrade Gen22019-07-15
10840682142875Discovery PET CT690 VCT Boost Upgrade2018-11-16
00840682102490RevolutionDiscovery CT2016-06-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850025268431Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2026-09-21
00860015781925Bunkerhill Contrast AVCBunkerhill Health Inc.JAK2026-09-16
B133ECTB422606160Cardiac ToolboxSYNTERMED INCORPORATEDKPS2026-07-02
B133NEUROQ412605150NeuroQSYNTERMED INCORPORATEDKPS2026-06-10
00850025268417Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2026-06-05
10810068810940MONARCH™ Advanced Imaging Accessory KitAuris Health, Inc.JAK2026-06-02
00860015781918iCAC DeviceBunkerhill Health Inc.JAK2026-05-31
10810068810841MONARCH™ Navigation SensorsAuris Health, Inc.JAK2026-05-27
00860015781901CAC (Gated) AlgorithmBunkerhill Health Inc.JAK2026-05-13
00850025268424Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2026-05-12
00198953085950PhotonovaGE Medical Systems, L.L.C.JAK2026-05-11
B133NEUROQ412601160NeuroQSYNTERMED INCORPORATEDKPS2026-03-04
00850025268400Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2026-02-27
B133ECTB422512090Cardiac ToolboxSYNTERMED INCORPORATEDKPS2026-02-26
00850025268394Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2026-01-21
00850025268387Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2025-11-03
00850025268370Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2025-09-24
B133NEUROQ412507140NeuroQSYNTERMED INCORPORATEDKPS2025-08-06
B133ECTB4225063000Emory Cardiac ToolboxSYNTERMED INCORPORATEDKPS2025-08-01
00850025268349Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2025-07-11
B133NEUROQ402505160NeuroQSYNTERMED INCORPORATEDKPS2025-06-18
00850025268363Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2025-06-03
00850025268356Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2025-05-23
00850025268332Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2025-05-16
08800025300299AVIEWCORELINE SOFT CO.,LTD.JAK2025-03-27
B133ECTB422503240Emory Cardiac ToolboxSYNTERMED INCORPORATEDKPS2025-03-26
08800025300367AVIEW CACCORELINE SOFT CO.,LTD.JAK2025-03-24
00850025268318Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2025-03-21
B133NEUROQ402503120NeuroQSYNTERMED INCORPORATEDKPS2025-03-21
00195278940292RevolutionGE Hangwei Medical Systems Company Ltd.JAK2025-02-28