FDA.reportPublic FDA data

UltraSPECT

Primary DI
00850040177145
Brand
UltraSPECT
Company
Ultraspect Usa, LLC
Model
4.0
Device description
WBR Imaging Xpress.PET
Published
2026-07-08
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

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
K103710000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K103710000WBR XPRESS PETUltraspect , Ltd.2011-01-19KPS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850040177145PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850040177145008500401771458500401771450850040177145

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.

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 DI, Brand, Model table
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
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
B133NEUROQ412605150NeuroQSYNTERMED INCORPORATEDKPS2026-06-10
00841962120548Alpine Stirrups, Metric, LeftQfixKPS2026-04-14
00841962120555Alpine Stirrups, Metric, RightQfixKPS2026-04-14
00859873006240HermiaHermes Medical Solutions ABKPS2026-03-05
B133NEUROQ412601160NeuroQSYNTERMED INCORPORATEDKPS2026-03-04
B133ECTB422512090Cardiac ToolboxSYNTERMED INCORPORATEDKPS2026-02-26
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
00841962120395Symphony Locating Bar, PH StyleQfixKPS2025-12-02
10841962119457Symphony Locating Bar, Prodigy2™QfixKPS2025-10-23
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