FDA.report

UltraSPECT

Primary DI
00850040177060
Brand
UltraSPECT
Company
Ultraspect Usa, LLC
Model
4.38.3.3
Device description
WBR Imaging X + X3 + Bone/Xact
Published
2022-05-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
KPSSystem, Tomography, Computed, Emission

Product Code Classifications

CodeDeviceSpecialtyClass
KPSSystem, Tomography, Computed, EmissionRadiology2

Premarket Submissions

SubmissionSupplement
K080784000

Premarket Details

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

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00850040177060PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00850040177060008500401770608500401770600850040177060

GMDN Terms

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

Regulatory Flags

DUNS number
118594942
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00850040177008UltraSPECT4.38.3.32022-05-20
00850040177015UltraSPECT4.38.3.32022-05-20
00850040177039UltraSPECT4.38.3.32022-05-20
00850040177046UltraSPECT4.38.3.32022-05-20
00850040177053UltraSPECT4.38.3.32022-05-20
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 DIBrandCompanyProduct codePublished
00859873006240HermiaHermes Medical Solutions ABKPS2026-03-05
B133NEUROQ412601160NeuroQSYNTERMED INCORPORATEDKPS2026-03-04
B133ECTB422512090Cardiac ToolboxSYNTERMED INCORPORATEDKPS2026-02-26
07290108670523D-SPECT RefurbishedSPECTRUM DYNAMICS MEDICAL, INCKPS2026-02-09
04068151048070Biograph Trinion.X EP9 CT64SIEMENS MEDICAL SOLUTIONS USA, INC.KPS2026-01-09
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
04068151048063Biograph Trinion.X EP9 CT128SIEMENS MEDICAL SOLUTIONS USA, INC.KPS2025-08-28
B133NEUROQ412507140NeuroQSYNTERMED INCORPORATEDKPS2025-08-06
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
30815112021543HeartSee Cardiac PET Processing SoftwareBracco Diagnostics Inc.KPS2025-07-25
07290108670097D-SPECT RefurbishedSPECTRUM DYNAMICS MEDICAL, INCKPS2025-06-30
B133NEUROQ402505160NeuroQSYNTERMED INCORPORATEDKPS2025-06-18
04540217072798PositViewSHIMADZU CORPORATIONKPS2025-05-16
B133ECTB422503240Emory Cardiac ToolboxSYNTERMED INCORPORATEDKPS2025-03-26
B133NEUROQ402503120NeuroQSYNTERMED INCORPORATEDKPS2025-03-21
06430070844015cNeuro cPETCombinostics OyKPS2025-02-24
00850031455016RADIALIS PET CAMERARadialis IncKPS2025-02-07
B133NEUROQ40241250NeuroQSYNTERMED INCORPORATEDKPS2025-01-27
00859873006189HermiaHermes Medical Solutions ABKPS2024-12-10
04540217071630SET-5002SHIMADZU CORPORATIONKPS2024-12-04
08437018413188CAREMIBRAINGENERAL EQUIPMENT FOR MEDICAL IMAGING SAKPS2024-05-28
00195278870490StarGuide MDD to MDR UpgradeG E MEDICAL SYSTEMS ISRAEL LTD.KPS2024-05-16