FDA.reportPublic FDA data

NA

Primary DI
00840682125697
Brand
NA
Company
GE Medical Systems, L.L.C.
Model
5775930
Device description
DV to PETMR PGR Upgrades, MP26
Published
2017-10-30
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840682125697PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840682125697008406821256978406821256970840682125697

GMDN Terms#

Term, Definition table
TermDefinition
Full-body MRI system, superconducting magnetA diagnostic general-purpose magnetic resonance imaging (MRI) system designed to scan any targeted area of the body (full-body imaging). This system includes a superconducting magnet assembly and can be fixed-location, mobile, or transportable. Some systems can perform MR spectroscopy or various real-time imaging procedures for MRI guided interventional, therapeutic, or surgical applications. The system is available in a variety of system gantry configurations including closed bore, open bore, and open-sided or other kinds of patient accessible designs.

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