FDA.reportPublic FDA data

UltraSPECT

Primary DI
00850040177046
Brand
UltraSPECT
Company
Ultraspect Usa, LLC
Model
4.38.3.3
Device description
WBR Imaging X + Bone/Xact
Published
2022-05-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KPSSystem, Tomography, Computed, Emission

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KPSSystem, Tomography, Computed, EmissionRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K080784000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K080784000WBR XPRESS.CARDIAC, WBR XPRESS.BONE; WBR XACT.CARDIAC, WBR XACT.BONEUltraspect , Ltd.2008-04-02KPS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850040177046PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850040177046008500401770468500401770460850040177046

GMDN Terms#

Term, Definition table
TermDefinition
SPECT system application softwareAn individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to a single photon emission computed tomography (SPECT) imaging system configuration. A basic set of applications programs and routines is included with such computer-controlled imaging systems and they can be upgraded to correct programming errors or to add new system capabilities. Some packages must be combined with specific hardware or firmware configurations in order to function as intended. Applications program packages are typically identified by a proprietary name and "version" or "upgrade" number.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118594942
Device count
1
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850040177008UltraSPECT4.38.3.32022-05-20
00850040177015UltraSPECT4.38.3.32022-05-20
00850040177039UltraSPECT4.38.3.32022-05-20
00850040177053UltraSPECT4.38.3.32022-05-20
00850040177060UltraSPECT4.38.3.32022-05-20
00850040177077UltraSPECT4.38.3.32022-05-20
00850040177084UltraSPECT4.38.3.32022-05-20
00850040177091UltraSPECT4.38.3.32022-05-20
00850040177107UltraSPECT4.38.3.32022-05-20
00850040177114UltraSPECT4.38.3.32022-05-20
00850040177121UltraSPECT4.38.3.32022-05-20
00850040177022UltraSPECT4.38.3.32022-05-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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B133NEUROQ412601160NeuroQSYNTERMED INCORPORATEDKPS2026-03-04
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07290108670523D-SPECT RefurbishedSPECTRUM DYNAMICS MEDICAL, INCKPS2026-02-09
04068151020472BIOGRAPH OneSiemens Healthineers AGKPS2026-01-20
00841962120456Alta for HexaPODQfixKPS2026-01-14
04068151048070Biograph Trinion.X EP9 CT64SIEMENS MEDICAL SOLUTIONS USA, INC.KPS2026-01-09
00841962120388Lumen AirShuttleQfixKPS2025-12-02
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10841962119464Symphony Locating Bar, PH StyleQfixKPS2025-10-23
08809873532005BRIGHTONIXBrightonix Imaging Inc.KPS2025-09-23
08809873532012BRIGHTONIXBrightonix Imaging Inc.KPS2025-09-23
08809873532029BRIGHTONIXBrightonix Imaging Inc.KPS2025-09-23
08809873532036BRIGHTONIXBrightonix Imaging Inc.KPS2025-09-23
08809873532043BRIGHTONIXBrightonix Imaging Inc.KPS2025-09-23
08809873532050BRIGHTONIXBrightonix Imaging Inc.KPS2025-09-23
00841439114841ZiFix TraverseMEDTEC, INC.KPS2025-09-12
00841962120340Edge Guide SystemQfixKPS2025-09-11
00198953061329NMCT 860G E MEDICAL SYSTEMS ISRAEL LTD.KPS2025-09-09
00198953061336NMCT 850G E MEDICAL SYSTEMS ISRAEL LTD.KPS2025-09-09
04068151048063Biograph Trinion.X EP9 CT128SIEMENS MEDICAL SOLUTIONS USA, INC.KPS2025-08-28
B133NEUROQ412507140NeuroQSYNTERMED INCORPORATEDKPS2025-08-06
06971576832033uMIShanghai United Imaging Healthcare Co., Ltd.KPS2025-08-03
06971576832163uMIShanghai United Imaging Healthcare Co., Ltd.KPS2025-08-03
06971576832231uMIShanghai United Imaging Healthcare Co., Ltd.KPS2025-08-03
06971576832255uMIShanghai United Imaging Healthcare Co., Ltd.KPS2025-08-03
B133ECTB4225063000Emory Cardiac ToolboxSYNTERMED INCORPORATEDKPS2025-08-01