FDA.reportPublic FDA data

NA

Primary DI
00840682145954
Brand
NA
Company
GE Medical Systems, L.L.C.
Model
SIGNA PET MR SPiCE Workstation
Device description
PETMR SPiCE Workstation Medical Device Assembly
Published
2020-06-22
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
K163619000

Premarket Details#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840682145954PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840682145954008406821459548406821459540840682145954

GMDN Terms#

Term, Definition table
TermDefinition
PET/MRI systemA diagnostic radiological imaging system that is a combination of a positron emission tomography (PET) camera system for nuclear medicine (NM) images, and a magnetic resonance imaging (MRI) system for magnetic resonance images. The nuclear medicine images and the magnetic resonance images may be registered and displayed in a fused format (overlaid in the same orientation) for the anatomical localization of the nuclear medicine data (i.e., distribution of radiopharmaceuticals). The PET and MRI portions of the system may be used independently or in combination; their images may be transferred to other systems for additional processing.

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