FDA.reportPublic FDA data

UltraSPECT

Primary DI
00850040177114
Brand
UltraSPECT
Company
Ultraspect Usa, LLC
Model
4.38.3.3
Device description
WBR Imaging X3 + Bone/Xact + ACSC
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
LLZSystem, Image Processing, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KPSSystem, Tomography, Computed, EmissionRadiology2
LLZSystem, Image Processing, RadiologicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K030870000
K031874000
K040370000
K081201000
K091073000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K030870000WBR, MODEL HRU.C.G. Technologies , Ltd.2003-04-09KPS
K031874000MODIFICATION TO WBR, MODEL HRU.C.G. Technologies , Ltd.2003-07-18KPS
K040370000WBR-FHR, WBR-FWBUltraspect , Ltd.2004-03-11KPS
K081201000WBR XPRESS3.CARDIACUltraspect , Ltd.2008-05-28KPS
K091073000WBR XPRESS.CARDIAC AND XPRESS3.CARDIAC INCLUDING ATTENUATION AND SCATTERING CORRECTIONSUltraspect , Ltd.2009-05-14KPS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850040177114PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850040177114008500401771148500401771140850040177114

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
00850040177145UltraSPECT4.02026-07-08
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
00850040177121UltraSPECT4.38.3.32022-05-20
00850040177022UltraSPECT4.38.3.32022-05-18

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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TKRL0001F1540PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F1B80PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F34K0PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F6000PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F7300PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F7940PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F7F80PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F9F00PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001FF640PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001FLI00PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001KF5I0PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001L0LD0PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001L4120PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001L7FI0PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001L9260PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL000200F30PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL000201K20PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL000202L80PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL000203ID0PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL000205I00PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0002066I0PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL000207330PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL000208K50PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0002098I0PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL000209F30PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL00020D0F0PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL00020F080PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL00020F670PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL00020I510PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20