Pure Global

GE Discovery NM 630 Nuclear Medicine Imaging System - HSA Registration DE0014197

Access comprehensive regulatory information for GE Discovery NM 630 Nuclear Medicine Imaging System in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0014197 and owned by GE Healthcare. The device was registered on October 30, 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.

Free Database
Powered by Pure Global AI
HSA Official Data
CLASS B
DE0014197
GE Discovery NM 630 Nuclear Medicine Imaging System
HSA Registration Number: DE0014197
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Product Description

Intended for use by trained healthcare professionals for patients of all ages to aid in detecting, localizing, diagnosing of diseases & in assessment of organ function for the evaluation of diseases, trauma, abnormalities, & disorders such as, cardiovascular disease, neurological disorders & cancer. The system output can be used by the physician for staging & restaging of tumors, planning, guiding, & monitoring therapy. It is a Nuclear Medicine (NM) system, which yields general NM imaging procedures for detection of radioisotope tracer uptake in the patientโ€™s body, using various scanning modes supported by various acquisition types & imaging features designed to enhance image quality.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Radiology / Imaging
Registration Information
Registration Number
DE0014197
Registration Date
October 30, 2013
Change Notification Approval Date
July 05, 2017
Retention Due Date
October 29, 2025
Product Owner
Short Name
GE Healthcare
Address
GE Medical Systems Israel, 4 Hayozma Street,, Tirat Hacarmel, 30200, Israel, 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)
Infant Positioner R-MADE ARMREST FOAM ARMREST CONTOURED LEG REST 17 LCD MILL ACQ MONITOR IVY 3000M RWAVE TRIG INFINIA BAR PHANTOM NM QA SOURCE HOLDER D670 & D630 GANTRY & Detector XELERIS 3 WORKSTATION FOR CAMERA INTG X3 Z400 WORKSTATION XELERIS 3 S/W D670 QC POINT SOURCE HLDR D670 PALLET EXTENDER D670 QC FLOOD SRCHLDR KIT D670 MEGP COLL 2 W_CART D670 LEHR COLL 2 W_CART D670 NM DOLLIES D670 ELEGP COLL(2)W/CART D670 HEGP COLL(2) W/CART D670 PINHOLE (1) W/CART D630 IMAGING TABLEย  D630 ACQ PACKAGE D630 INSTALLTION KIT NORAV D630 NM ACQ SYSTEM CH IVY 3000M RWAVE TRIG+REC Axial Head Holder NM 600 LEUHR D670 STRAPS&PAD KIT D670-D630 TOUCH RULER IVY 3000M RWAVE TRIG+REC IVY 3000M RWAVE TRIG IVY 3000M RWAVE+CART IVY 3000M RWAVE+REC+CART NORAV ECG GATING FOR D630 D630 LEHR COLLIMATOR W/cart D630 MEGP COLLIMATOR W/cart D670 ELEGP COLL(2)W/CART D670 HEGP COLL(2) W/CART D670 PINHOLE (1) W/CART D670 FANBEAM (2) W/CART NM 600 LEUHR NM600 LEHS coll w cart Infant Scan Support Discovery 670 NM GANTRY Discovery 670 NM DETECTOR 3/8" D670 STRAPS&PAD KIT Axial Head Holder D670 NM DOLLIES D670 PALLET EXTENDER Discovery 630 IMAGING TABLEย  5/8โ€ NM Detector D670-D630 TOUCH RULER Discovery NM 630 System 3/8" ACQ Discovery NM 630 System 5/8" ACQ D630 ACQ PACKAGE D630 INSTALLATION KIT XELERIS 3 S/W XELERIS 3 WORKSTATION FOR CAMERA INTG X3 Z400 WORKSTATION
Model Identifier(s)
E8003S E8500NA E8500NB E8500NC H2400ME H2400MJ H2400MK H2400YL H2401KA H2401KJ H2401KN H2401KR H2401KW H2401KY H2401KZ H2401LA H2401LB H2401LC H2401LE H2401LF H2401LG H2401LL H2401LM H2401LN H2401LR H2401LW H2401LY H2401MS H2401NH H2401NP H2401WG H2505JW H2505JY H2505K H2505KA H2506KR H2506TB H2506TC H2506TD H2506TE H2506TF H2506TG H2506TH H2506TY H3100JT H3100NC H3100ND H3100NP H3100NW H3100PB H3100PG H3100PM H3100PN H3100PS H3100RC H3100RD H3100RE H3100RG H3901KD H3901KE H3901RD