FDA.reportPublic FDA data

NM600

Primary DI
00840682138376
Brand
NM600
Company
G E MEDICAL SYSTEMS ISRAEL LTD.
Model
INFANT SCAN SUPPORT
Published
2018-09-26
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
KXHCradle, patient, radiologic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KXHCradle, Patient, RadiologicRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840682138376PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840682138376008406821383768406821383760840682138376

GMDN Terms#

Term, Definition table
TermDefinition
Radiological whole-body positionerA device comprised of fixed or adjustable position elements designed to ensure adequate positioning and/or immobilization of a patient's whole body during diagnostic imaging, image guided surgical or interventional procedures, and/or radiation therapy procedures; it may in addition be used to position a patient’s body part (however it is not dedicated to a specific part of the body). It is in the form of a frame, board, cushion, or preformed pad and may be used to facilitate reproducible positioning for serial imaging studies or serial radiation therapy treatments.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
532102365
Device count
1
Premarket exempt
true
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
00198953061329NMCT 860H3908BJ, H3908BH2025-09-09
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850043319153Hyperfine Foam Back PadHyperfine Operations, Inc.KXH2026-05-26
07640178060753MultipadPearl Technology AGKXH2025-12-17
07640178060760PearlFitPearl Technology AGKXH2025-12-17
07640178060852PearlFitPearl Technology AGKXH2025-12-17
07640178060906PearlFitPearl Technology AGKXH2025-12-17
07640178060982ProFoamPearl Technology AGKXH2025-12-17
07640178060999ProFoamPearl Technology AGKXH2025-12-17
07640178061002ProFoamPearl Technology AGKXH2025-12-17
07640178061019ProFoamPearl Technology AGKXH2025-12-17
07640178061750ProFoamPearl Technology AGKXH2025-12-17
07640178061767ProFoamPearl Technology AGKXH2025-12-17
07640178061774ProFoamPearl Technology AGKXH2025-12-17
07640178061781ProFoamPearl Technology AGKXH2025-12-17
07640178061804ProBeltPearl Technology AGKXH2025-12-17
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07640178061866ProFoamPearl Technology AGKXH2025-12-17
07640178061873ProFoamPearl Technology AGKXH2025-12-17
07640178061880ProFoamPearl Technology AGKXH2025-12-17
07640178061897ProBeltPearl Technology AGKXH2025-12-17
07640178061903ProFoamPearl Technology AGKXH2025-12-17
07640178061910ProFoamPearl Technology AGKXH2025-12-17
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07640178062108ProFoamPearl Technology AGKXH2025-12-17
07640178062115ProFoamPearl Technology AGKXH2025-12-17
07640178062122ProFoamPearl Technology AGKXH2025-12-17
07640178062139ProFoamPearl Technology AGKXH2025-12-17
07640178062146ProFoamPearl Technology AGKXH2025-12-17
07640178062153ProFoamPearl Technology AGKXH2025-12-17
07640178062078pearltecPearl Technology AGKXH2025-07-28