DEVICE: D-SPECT ® processing and Reviewing Workstation (07290108670080)
Device Identifier (DI) Information
D-SPECT ® processing and Reviewing Workstation
Stand Alone
Not in Commercial Distribution
8010113-01
SPECTRUM DYNAMICS MEDICAL, INC
Stand Alone
Not in Commercial Distribution
8010113-01
SPECTRUM DYNAMICS MEDICAL, INC
Single Photon Emission Computed Tomography system, stand alone processing station.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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40934 | SPECT system workstation |
A 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.
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FDA Product Code
[?]Product Code | Product Code Name |
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LLZ | System, Image Processing, Radiological |
KPS | System, Tomography, Computed, Emission |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
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No Device Sizes |
Device Record Status
44d02b05-fa55-410b-a5ab-dce96c50d918
December 23, 2022
4
October 25, 2017
December 23, 2022
4
October 25, 2017
Alternative and Additional Identifiers Additional Identifiers
Package DI
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Secondary DI
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
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No Customer Contact currently defined