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GE Discovery NM 750b Nuclear Medicine Imaging System - HSA Registration DE0018119

Access comprehensive regulatory information for GE Discovery NM 750b 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 DE0018119 and owned by GE Medical Systems Israel, Functional Imaging. The device was registered on May 13, 2016.

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 B
DE0018119
GE Discovery NM 750b Nuclear Medicine Imaging System
HSA Registration Number: DE0018119
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Product Description

The Discovery NM 750b Gamma Camera is intended to measure and image the distribution of selected single photon emission radioisotopes in the human body to aid in the evaluation of lesions. The resultant images are intended to be reviewed by qualified medical professionals. The Discovery NM 750b Gamma Camera is intended for diagnostic imaging of the breast and other small body parts. The Discovery NM 750b Gamma Camera when used for breast imaging is intended as an adjunct to mammography or other breast imaging modalities (it is not intended for primary screening of the population).

Device Classification
Device Class
CLASS B
Medical Speciality Area
Radiology / Imaging
Registration Information
Registration Number
DE0018119
Registration Date
May 13, 2016
Retention Due Date
May 12, 2025
Product Owner
Short Name
GE Medical Systems Israel, Functional Imaging
Address
4 Hayozma Street, 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)
UPS, Powercom ULT 2000-LC UPS, GE VH-3000 17โ€ LCD MILL ACQ Monitor D750B DUAL DETECTOR SET D750B GANTRY D750B ACQ D750B ACQ SSP D750B SSP Dongle - 100 D750B SSP Dongle - 200 D750B SSPDongle - 500 Acquisition 15m cable Mobile Acquisition Cart Wall Mounted Acquisition Station XFL 1st client XELERIS 3 SERVER LICENSE X3 FOR MBI + 1 XFL MBI VIEWER D750B DH INT SYSTEM Hydraulic chair D750B DH ACQ SYSTEM D750B DH INT SYSTEM D750B DH ACQ SSP SYSTEM D750B DH INT SSP SYSTEM
Model Identifier(s)
E4502KB E45151ND H2506KK H3100SB H3100SC H3100SD H3100SH H3100ST H3100SW H3100SY H3100SZ H3602RK H3602RS H3900MA H3901KK H3901TH H3901TJ S0750DH S30311HT S8000PA S8000PB S8000PE S8000PZ