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GE Optima NM/CT 640 - HSA Registration DE0013296

Access comprehensive regulatory information for GE Optima NM/CT 640 in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0013296 and owned by GE Medical Systems Israel. The device was registered on July 08, 2013.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

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CLASS C
DE0013296
GE Optima NM/CT 640
HSA Registration Number: DE0013296
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Product Description

The Optima NM/CT 640 system is intended for General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includes a general purpose Nuclear Medicine (NM) system using a variety of scanning modes supported by various acquisition types, and a CT component which is intended specifically for enabling attenuation correction and anatomical localization on SPECT studies.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Radiology / Imaging
HSA Product Code
Refer to CRPNS
HS Code
90221200
Registration Information
Registration Number
DE0013296
Registration Date
July 08, 2013
Change Notification Approval Date
June 04, 2019
Retention Due Date
July 07, 2025
Product Owner
Short Name
GE Medical Systems ISRAEL
Address
4, Hayozma Street, P.O Box 170, Tirat Hacarmel 30200, ISRAEL
Registrant
Address
11 NORTH BUONA VISTA DRIVE, THE METROPOLIS, #11-07, SINGAPORE 138589
Importer
Address
11 NORTH BUONA VISTA DRIVE, THE METROPOLIS, #11-07, SINGAPORE 138589 1 MARITIME SQUARE, HARBOURFRONT CENTRE, #13-01, SINGAPORE 099253 1 MARITIME SQUARE, HARBOURFRONT CENTRE, #13-01, SINGAPORE 099253
Model Information
Model Name(s)
NM/CT 670 table NM operator console NM gantry Optima NM/CT 640 CT gantry R-MADE ARMREST FOAM ARMREST CONTOURED LEG REST IVY 3000M RWAVE TRIG+REC IVY 3000M RWAVE TRIG IVY 3000M RWAVE+CART IVY 3000M RWAVE+REC+CART 17" LCD Mill Acq Monitor D670 DETECTOR 3/8” D670 STRAPS & PAD KIT Axial Head Holder D670 PALLET EXTENDER D670 DETECTOR 5/8” OPTIMA NM/CT 640 – 3/8” CRYSTAL CUSTOM SYSTEM OPTIMA NM/CT 640 – 3/8” CRYSTAL EXCEL SYSTEM Optima NM/CT 640 – 5/8” CRYSTAL EXCEL SYSTEM O640 CONNECTING KIT XELERIS3 WORKSTATION FOR CAMERA INTG
Model Identifier(s)
5363260-xx 5370540-xx 5376204-XX 5670100-XX E8500NA E8500NB E8500NC H2505JW H2505JY H2505K H2505KA H2506KK H3100ND H3100NP H3100NW H3100PG H3100PN H3100YA H3100YC H3100YD H3100YG H3901KE