FDA.reportPublic FDA data

D-SPECT ® processing and Reviewing Workstation

Primary DI
07290108670080
Brand
D-SPECT ® processing and Reviewing Workstation
Company
SPECTRUM DYNAMICS MEDICAL, INC
Model
Stand Alone
Catalog number
8010113-01
Device description
Single Photon Emission Computed Tomography system, stand alone processing station.
Published
2017-10-25
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K160120000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160120000D-SPECT Processing and Reviewing WorkstationSpectrum Dynamics , Ltd.2016-03-21KPS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290108670080PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290108670080072901086700807290108670080

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.

Sterilization Methods#

Method table
Method

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
07290108670233TruSPECT STANDALONE PROCESSING STATION8010290-012022-12-26
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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