FDA.reportPublic FDA data

NM600

Primary DI
00840682138383
Brand
NM600
Company
G E MEDICAL SYSTEMS ISRAEL LTD.
Model
HEAD HOLDER
Published
2018-04-09
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
IWYHolder, head, radiographic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IWYHolder, Head, RadiographicRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840682138383PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840682138383008406821383838406821383830840682138383

GMDN Terms#

Term, Definition table
TermDefinition
Radiological headrestA non-sterile device intended to facilitate adequate positioning and immobilization of the patient's head and neck for reproducible positioning during diagnostic imaging procedures, image-guided surgical or interventional procedures, and/or radiation therapy procedures. The device is in the form of a frame, cushion, or preformed pad that is intended to directly contact the head, and which may be customizable for single-patient use. This is a reusable device.

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
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04719879741216Blessing CathayBLESSING CATHAY CORPORATIONIWY2025-07-21
04719879741223Blessing CathayBLESSING CATHAY CORPORATIONIWY2025-07-21
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04719879741247Blessing CathayBLESSING CATHAY CORPORATIONIWY2025-07-21
04719879741162Blessing CathayBLESSING CATHAY CORPORATIONIWY2025-07-11
04719879741285Blessing CathayBLESSING CATHAY CORPORATIONIWY2025-07-10
04719879741261Blessing CathayBLESSING CATHAY CORPORATIONIWY2025-07-09
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04719879741292Blessing CathayBLESSING CATHAY CORPORATIONIWY2025-07-09
04719879741308Blessing CathayBLESSING CATHAY CORPORATIONIWY2025-07-09
04719879741315Blessing CathayBLESSING CATHAY CORPORATIONIWY2025-07-09
04719879741322Blessing CathayBLESSING CATHAY CORPORATIONIWY2025-07-09
04719879741339Blessing CathayBLESSING CATHAY CORPORATIONIWY2025-07-09
00810004900622Neocis Guidance SystemNEOCIS INCIWY2025-05-02
00850043319146Head StabilizerHyperfine Operations, Inc.IWY2024-12-11
00810050245531NADOMICO MED-DEVICE, LLCIWY2024-06-21
06977071930014MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWY2024-06-21
06977071930069MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWY2024-06-21
00810050245487NADOMICO MED-DEVICE, LLCIWY2023-05-01
G242RHIAB9Techno-AideTechno-Aide, Inc.IWY2023-02-13
00850043319047Hyperfine Foam Head PadHyperfine Operations, Inc.IWY2023-01-25
00840326416037PanoramicYoung Innovations, Inc.IWY2023-01-05
00887761972872Head-Positioning accessoriesBaxter Medical Systems GmbH + Co. KGIWY2023-01-05
00887761972889Head-Positioning accessoriesBaxter Medical Systems GmbH + Co. KGIWY2023-01-05