FDA.reportPublic FDA data

NMCT 860

Primary DI
00198953061329
Brand
NMCT 860
Company
G E MEDICAL SYSTEMS ISRAEL LTD.
Model
H3908BJ, H3908BH
Device description
NM_CT 860 NM Gantry Final MDR
Published
2025-09-09
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
K173816000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173816000NM/CT 850, NM/CT 860GE Healthcare2018-04-17KPS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00198953061329PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00198953061329001989530613291989530613290198953061329

GMDN Terms#

Term, Definition table
TermDefinition
Full-body CT systemAn assembly of diagnostic x-ray computed tomography (CT) devices with a gantry large enough to allow imaging of any part of the body. It includes designs with single or multiple fixed annular arrays of x-ray tubes and opposing detectors or those with x-ray tube(s) and opposing detector assemblies that rotate rapidly around a central axis point within the gantry imaging area. It can produce two and/or three-dimensional (3-D) cross-sectional (tomographic) images, including spiral CT or other special imaging applications at multiple specified angles in relation to body position. It may use a variety of digital techniques for information capture, image reconstruction, and display.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
532102365
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840682122771Vividi-q-S5-S6 BT12 UPG2017-01-19
00195278011343DaTQUANT2.02020-06-16
00195278614933Xeleris Processing and Review WorkstationV59279112025-10-31
00195278822383Xeleris Processing and Review WorkstationV2025-10-31
00198953061336NMCT 850H3907BE, H3907BF2025-09-09
00195278878502AuroraSPECT with Revolution Ascend CT2025-02-25
00195278870490StarGuide MDD to MDR Upgrade596242659624262024-05-16
00195278755544StarGuideH3911BJ5842898-102024-04-18
00195278794772D630 to D670 DR UpgradeH3101RS59530352024-03-18
00195278788252NM8305376204-332023-11-15
00195278788269NMCT870 DR2023-11-14
00195278488619MyoSPECTH3912BC5875815-302023-09-14
00195278488626MyoSPECT ESH3912BD5875815-402023-09-14
00195278722546MyoSEPCT ES to MyoSPECT UpgradeH3912BS59414452023-09-14
00195278592309OmniLegend2022-09-12
00195278421579MyoSPECT ESH3912AB5875815-202021-10-11
00195278421586MyoSPECTH3912AA5875815-102021-10-07
00195278245021Xeleris Processing and Review WorkstationV2021-05-12
00195278118295StarGuideH3911AB2021-05-10
00840682105286Discovery NM 530cH3000SA2016-08-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07649998522014NeuroLFPositrigo AGKPS2026-07-28
07649998522021NeuroLFPositrigo AGKPS2026-07-28
07649998522038NeuroLFPositrigo AGKPS2026-07-28
07649998522045NeuroLFPositrigo AGKPS2026-07-28
00850040177145UltraSPECTUltraspect Usa, LLCKPS2026-07-08
00860014944611nView s1 with nav optionNVIEW MEDICAL INC.JAK2026-07-08
B133NEUROQ412605150NeuroQSYNTERMED INCORPORATEDKPS2026-06-10
00850025268417Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2026-06-05
00856100006493Respiratory Gating for ScannersVARIAN MEDICAL SYSTEMS, INC.JAK2026-06-05
10810068810940MONARCH™ Advanced Imaging Accessory KitAuris Health, Inc.JAK2026-06-02
00860015781918iCAC DeviceBunkerhill Health Inc.JAK2026-05-31
10884521785977superDimensionCovidien LPJAK2026-05-29
10884521851184superDimensionCovidien LPJAK2026-05-29
10810068810841MONARCH™ Navigation SensorsAuris Health, Inc.JAK2026-05-27
10810068810858MONARCH™ ControllerAuris Health, Inc.JAK2026-05-27
00884838123748Spectral CT VeridaPhilips Medical Systems Nederland B.V.JAK2026-05-26
00884838126398Spectral CT Verida RTPhilips Medical Systems Nederland B.V.JAK2026-05-26
00884838127555Upgrade Spectral CT VeridaPhilips Medical Systems Nederland B.V.JAK2026-05-26
00884838127562Upgrade Spectral CT Verida RTPhilips Medical Systems Nederland B.V.JAK2026-05-26
00884838127883Upgrades Spectral CT 7500 RT SW5.4Philips Medical Systems Nederland B.V.JAK2026-05-26
M722CD26112CA252790ClearRead CT CAC DockerRiverain Technologies, Inc.JAK2026-05-07
08719326703824LungQ®Thirona B.V.JAK2026-02-12
10841962119457Symphony Locating Bar, Prodigy2™QfixJAK2025-10-23
10841962119457Symphony Locating Bar, Prodigy2™QfixKPS2025-10-23
10841962119464Symphony Locating Bar, PH StyleQfixJAK2025-10-23
10841962119464Symphony Locating Bar, PH StyleQfixKPS2025-10-23
M722C25281CA252790ClearRead CT CAC ServerRiverain Technologies, Inc.JAK2025-10-17
M722CC25281CA252790ClearRead CT CAC ConsoleRiverain Technologies, Inc.JAK2025-10-17
M722CD25281CA252790ClearRead CT CAC DockerRiverain Technologies, Inc.JAK2025-10-17
10810068811275Extended Patient Introducer MountAuris Health, Inc.JAK2025-09-04