NMCT

GUDID 00195278788269

870 DR NM GANTRY FINAL WITH NEW ROTOR - MDR CE

G E MEDICAL SYSTEMS ISRAEL LTD.

Stationary gamma camera system Stationary gamma camera system Stationary gamma camera system Stationary gamma camera system Stationary gamma camera system Stationary gamma camera system Stationary gamma camera system Stationary gamma camera system Stationary gamma camera system Stationary gamma camera system Stationary gamma camera system Stationary gamma camera system Stationary gamma camera system Stationary gamma camera system Stationary gamma camera system Stationary gamma camera system Stationary gamma camera system

Primary Device ID	00195278788269
NIH Device Record Key	bf4dd765-da92-484f-8ef4-42b3ee878e41
Commercial Distribution Status	In Commercial Distribution
Brand Name	NMCT
Version Model Number	870 DR
Company DUNS	532102365
Company Name	G E MEDICAL SYSTEMS ISRAEL LTD.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00195278788269 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K093514

FDA Product Code

JAK	System, x-ray, tomography, computed

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2023-11-22
Device Publish Date	2023-11-14

On-Brand Devices [NMCT]

00840682140843	870CZT
00840682140836	870 DR
00840682140775	850
00840682140751	860
00195278788269	870 DR NM GANTRY FINAL WITH NEW ROTOR - MDR CE