DEVICE: AnyScan (05999884132172)

Device Identifier (DI) Information

AnyScan
AnyScan S
In Commercial Distribution

MEDISO Kft.
05999884132172
GS1

1
401469804 *Terms of Use
SPECT Imaging System
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Device Characteristics

Labeling does not contain MRI Safety Information
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No
No
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GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
SPECT system, rotating detector head An assembly of devices comprising a diagnostic, stationary, single photon emission computed tomography (SPECT) system that is a three-dimensional (3-D) tomographic imaging gamma camera-based system used to detect, 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. The gantry is designed to rotate a collimated detector head or heads around the body in a pre-programmed motion sequence. The gantry position is typically fixed and the table moveable. The imaging capabilities of most SPECT systems include both static and dynamic imaging.
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FDA Product Code

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Product Code Product Code Name
KPS System, Tomography, Computed, Emission
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K131625 000
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Sterilization

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Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

eb69c3b7-ad0f-4d43-be6c-cd675780a12c
July 06, 2018
3
September 23, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
Yes
No
No
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Customer Contact

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No Customer Contact currently defined
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