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Shimadzu Flexavision X-ray system - HSA Registration DE0012706

Access comprehensive regulatory information for Shimadzu Flexavision X-ray system in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0012706 and owned by Shimadzu Corporation. The device was registered on April 03, 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
DE0012706
Shimadzu Flexavision X-ray system
HSA Registration Number: DE0012706
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Product Description

FLEXAVISION is an X-ray television system mainly aimed at diagnoses for chest and GI

Device Classification
Device Class
CLASS C
Medical Speciality Area
Radiology / Imaging
HSA Product Code
Refer to CRPNS
HS Code
90221400
Registration Information
Registration Number
DE0012706
Registration Date
April 03, 2013
Retention Due Date
April 02, 2026
Product Owner
Short Name
Shimadzu Corporation
Address
1 Nishinokyo-Kuwabaracho, Nakagyo-ku, Kyoto 604-8511, JAPAN
Registrant
Address
79 SCIENCE PARK DRIVE, CINTECH IV, #02-01/08, SINGAPORE 118264
Importer
Address
79 SCIENCE PARK DRIVE, CINTECH IV, #02-01, SINGAPORE 118264
Model Information
Model Name(s)
Lieder Cassette stand Compression band AVR-UD Cassette holder SPT-XD-A4A Phototimer pick-up (4 fields pick-up) 2nd tube option (Incl. Control panel and tube selector) Phototimer pick-up SPT-XD-A4A Phototimer pick-up SPT-XD-A4A DICOM Storage Option (Shimadzu Standard) DICOM MWM option (Shimadzu Standard) High-speed SERIAL option DSA option Phototimer controller for 2nd tube option Scan converter (for PAL) Scan converter (for NTSC) Lateral cassette holder FH-21HR Floor-to-wall/ceiling tube mount FH-20HR Floor-mount tube mount FH-21HR (CE) Floor-to-wall/ceiling tube mount FH-20HR (CE)Floor-mount tube mount R-20J Multi-leaf collimator R-20J (CE) Multi-leaf collimator Foot switch for examination room CH-200M Ceiling tube mount CH-200M (CE) Ceiling tube mount Cassette tray (14"x14") Compression belt R-20J(CH-200M) Multi-leaf collimator R-20J(CH-200M) (CE) Multi-leaf collimator BR-120M Wall bucky stand BR-120M (CE) Wall bucky stand Oblique projection unit, +/- 30degree Oblique projection unit with 1.5 FFD extenstion Imaging Chain Extension unit (1.8mt/2mt) Maximum allowable load up kit (150kg) Imaging unit speed up kit (for ZSU-5Dxx) Imaging unit speed up kit(for ZSU-5DSxx) CFRP table top G.I. Examination kit Grid change Change to: 34lines/cm, 8:1, fo=150cm 12" I.I. Mount Kit 9" I.I. Mount Kit X-rat tube swing out unit (37 deg) Auxiliary tabletop Drain Bag Monitor cart for CRT monitor and LCD Monitor For SF system Monitor cart for 2 LCD monitors Local console Desk-top type for SF (desk not included) Desk-top type for SF (desk not included) Communication unit ZUD Sub-divisional (up-down) spot (SFD) F/V SF DLF F/V SF DBF F/V SF DSLF F/V SF DSBF F/V HB DLF F/V HB DBF F/V HB DSLF F/V HB DSBF F/V FD DLF F/V FD DBF F/V FD DSLF F/V FD DSBF X-ray tube 180 degrees swing unit Sub-divisional (up-down) spot (SFD) Digital upgrade kit for 12" I.I. (SF) Digital upgrade kit for 9" I.I. (SF) I.I. mount kit 12TE XUD-type Console(Desk combined with console) XUD-type Console(Desk combined with console) Magnetic Shield #12B (Both for new and existing system) Magnetic Shield #9S I.I. Cable set#20 Active Magnetic Shield #T (Factory option. For new system) IA-12LD(IO) 9"/12" dual field Image Intensifier IA-12LM13(IO) 6"/7.5" /9"/12" Multi field Image Intensifier IA-12KD13(IO) 9"/12" dual field image intensifier IA-12KT13(IO) 6"/9"/12" triple field image intensifier Magnetic Shield #12K IA-9SZ 9" single field Image Intensifier IA-9SZ13 9" single field Image Intensifier 0.6/1.2P13DK-85 200kHU X-ray tube 0.6/1.2P33DK-85 200kHU High-speed X-ray tube 1/2P18DK-85 200kHU X-ray tube 1/2P38D-85 200kHU High-speed X-ray tube 0.3/0.8P18DK-85(SF) 200kHU tube 0.3/0.8P324DK-85(SF) 400kHU tube 0.6/1.2P324DK-85(SF) 400kHU tube 0.6/1.2P164DK-85 400kHU X-ray tube 0.6/1.2P364DK-85 400kHU High-speed tube 0.6/1.2P18DE-85(SF) 200kHU tube 0.6/1.2P38DE-85(SF) 200kHU tube 1/2P13DK-85 200kHU X-ray tube 1/2P33D-85 200kHU High-speed X-ray tube 0.3/0.8P323DK-85(SF) 300kHU tube 0.8P323DK-85(SF) 300kHU tube Accessory pack, 18RF Accessory pack, 18R
Model Identifier(s)
046-70420-01 501-23092-01 501-74941 501-95043-04 502-22087-01 502-25680-02 502-25681-01 502-25681-02 502-25965-31 502-25965-32 502-25965-61 502-25965-63 502-26184 502-26267 502-26311 503-25140 503-43000-01 503-43000-02 503-43000-15 503-43000-16 503-55060 503-55061 503-55173 503-58100 503-58100-03 503-58538-04 503-58928 503-59650 503-59650-01 503-61800-01 503-61800-02 503-63009 503-63009-01 503-63016 503-63017 503-63018-01 503-63018-02 503-63019 503-63020-04 503-63046 503-66104 503-66105 503-66356 503-66360 503-66362 503-67551-02 503-67551-03 503-67751 503-67752 503-67752-01 503-67777 503-69247 503-70400-01 503-70400-03 503-70400-04 503-70400-06 503-70400-11 503-70400-13 503-70400-14 503-70400-16 503-70400-21 503-70400-23 503-70400-24 503-70400-26 503-70637 503-71021 503-71075-02 503-71075-12 503-74679 511-89059 511-89159 532-16371 532-16702 532-16743-15 532-16750-01 532-16881-50 532-16883-65 532-16887-65 532-16888-65 532-16910 532-17200 532-17200-15 532-24476 532-24477 532-24480 532-24481 532-24483 532-24484 532-24486 532-24487 532-24488 532-24556 532-24558 532-24560 532-24562 532-24564 532-24565 532-24827-01 532-24827-03