DEVICE: NM (00195278788252)
Device Identifier (DI) Information
NM
830
In Commercial Distribution
5376204-33
G E MEDICAL SYSTEMS ISRAEL LTD.
830
In Commercial Distribution
5376204-33
G E MEDICAL SYSTEMS ISRAEL LTD.
830 NM GANTRY FINAL WITH NEW ROTOR - MDR CE
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
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? |
---|---|---|---|---|
40640 | Stationary gamma camera system |
An assembly of static diagnostic devices designed to record, quantify, and analyse radionuclide emissions (primarily gamma rays) produced during the decay of radiopharmaceuticals or other radiation emitting materials injected into, or ingested by, a patient. It consists of an analogue or digital detector based nuclear medicine (NM) planar imaging system, crystal(s), a collimator and a set of photomultiplier tubes or photo diodes. Gamma rays pass through holes in the collimator causing light flashes within the crystal corresponding to the sites of origin in the body and the amplitude of the flash is calculated by a computer to create images.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KPS | System, tomography, computed, emission |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K111445 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
c0172f56-69b2-4626-b288-8eb2946c427d
November 23, 2023
1
November 15, 2023
November 23, 2023
1
November 15, 2023
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined