FDA.reportPublic FDA data

NA

Primary DI
00840682105378
Brand
NA
Company
GE Medical Systems, L.L.C.
Model
SIGNA PET MR
Device description
PET MR System Medical Device Assembly
Published
2016-08-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
OUOTomographic imager combining emission computed tomography with nuclear magnetic resonance

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OUOTomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic ResonanceRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K142098000
K163619000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142098000SIGNA PET/MRGe Medical Systems, LLC2014-11-24OUO
K163619000SIGNA PET/MRGe Medical Systems, LLC2017-02-14OUO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840682105378PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840682105378008406821053788406821053780840682105378

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
160032025
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840682138796Revolution160mm Detector Upgrade2018-01-11
00198953085950PhotonovaSpectra5590000-502026-05-11
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
00840682102995DiscoveryPETCT 7102016-08-01
00840682103107DiscoveryIQ2016-08-01
00840682104364Definium50002016-08-01
00840682108218DiscoveryMI2016-10-11
00840682115261OptimaXR220amx2016-08-01
00840682115278OptimaXR200amx2016-08-01
00840682119238Precision500D2016-08-01
00840682119658NA54216982016-08-01
00840682120975DiscoveryMI Digital Ready2016-10-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841962120548Alpine Stirrups, Metric, LeftQfixOUO2026-04-14
00841962120555Alpine Stirrups, Metric, RightQfixOUO2026-04-14
04068151020472BIOGRAPH OneSiemens Healthineers AGOUO2026-01-20
00841962120456Alta for HexaPODQfixOUO2026-01-14
00841962120388Lumen AirShuttleQfixOUO2025-12-02
00841962120395Symphony Locating Bar, PH StyleQfixOUO2025-12-02
10841962119457Symphony Locating Bar, Prodigy2™QfixOUO2025-10-23
00841439114841ZiFix TraverseMEDTEC, INC.OUO2025-09-12
00841962120340Edge Guide SystemQfixOUO2025-09-11
00841962119467Alpine StirrupsQfixOUO2025-07-09
00841962119474Alpine StirrupsQfixOUO2025-07-09
00841962119481Symphony™QfixOUO2025-07-09
00841962119498AirDrive Trolley™QfixOUO2025-07-09
00841962119528AirShuttle Locating BarQfixOUO2025-07-09
00841962119535AirShuttle Locating BarQfixOUO2025-07-09
00841962119542AirShuttle Transfer HandleQfixOUO2025-07-09
00841962119559InfinityLock™QfixOUO2025-07-09
00841962119573AirShuttle Transfer HandleQfixOUO2025-07-09
00841962119580InfinityLock™QfixOUO2025-07-09
00841962119597AltaQfixOUO2025-07-09
00841962119603AltaQfixOUO2025-07-09
00841962119689Stradivarius™QfixOUO2025-07-09
00841962119696Encompass™QfixOUO2025-07-09
00841962119702Encompass™QfixOUO2025-07-09
00841962119719Encompass™QfixOUO2025-07-09
00841962119726AltaQfixOUO2025-07-09
00841962119733AltaQfixOUO2025-07-09
00841962119740AltaQfixOUO2025-07-09
00841962119757InfinityLock™QfixOUO2025-07-09
00841962119764AltaQfixOUO2025-07-09