FDA.reportPublic FDA data

TruSPECT

Primary DI
07290108670233
Brand
TruSPECT
Company
SPECTRUM DYNAMICS MEDICAL, INC
Model
STANDALONE PROCESSING STATION
Catalog number
8010290-01
Device description
TruSPECT Radiological Image Processing Station
Published
2022-12-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological
QIHAutomated Radiological Image Processing Software

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2
QIHAutomated Radiological Image Processing SoftwareRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K212230000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212230000TruSPECT Radiological Image Processing StationSpectrum Dynamics Medical, Ltd.2021-08-16LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290108670233PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290108670233072901086702337290108670233

GMDN Terms#

Term, Definition table
TermDefinition
SPECT system workstationA freestanding, image processing device that is a component of single photon emission computed tomography (SPECT) system. It is sometimes considered to be a component to a picture archiving and communication system (PACS). It does not contain the controls for the direct operation of the diagnostic imaging system. It can receive and transmit data both on-line and off-line and is typically located at a site remote from the operator's console. It has the capability to further process, manipulate and/or view patient images and information collected from one or more nuclear medicine based imaging systems.

Regulatory Flags#

DUNS number
078864620
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290108670523D-SPECT RefurbishedD-SPECT 0028010517-012026-02-09
07290108670097D-SPECT Refurbished0028010517-012025-06-30
07290108670042D-SPECT® L0018010020-012016-09-22
07290108670172VERITON CTVERITON CT 4168010421-012023-06-01
07290108670189VERITON CTVERITON CT 4648010422-012023-06-01
07290108670202VERITON NM3008010426-012023-06-01
07290108670219VERITON CTVERITON CT 3648010420-012023-06-01
07290108670226VERITON CTVERITON CT 3168010419-012023-06-01
07290108670240VERITON NM4008010427-012023-06-01
07290108670080D-SPECT ® processing and Reviewing WorkstationStand Alone8010113-012017-10-25
07290108670004D-SPECT®0038010029-012016-09-22
07290108670011D-SPECT®0048010029-012016-09-22
07290108670028D-SPECT®0038010018-012016-09-22
07290108670035D-SPECT®0048010018-012016-09-22
07290108670059D-SPECT® L0018010032-012016-09-22
07290108670158D-SPECT RefurbishedD-SPECT 0048010013-012020-08-26
07290108670141D-SPECT VISTA0028010267-012020-06-28
00729018670158D-SPECT RefurbishedD-SPECT 0048010013-012020-08-26
07290108670134D-SPECT VISTA 0028010266-012020-06-28
00729018670141D-SPECT VISTA0028010267-012020-06-28

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00817886020578JointsMEDSTRAT, INC.LLZ2024-04-12
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00754016387111ANDIImeka Solutions IncQIH2023-09-01
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