DEVICE: IA-16LD/HS13 (04540217020249)

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Device Record History
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Device Identifier (DI) Information
IA-16LD/HS13
532-16728-15
In Commercial Distribution

SHIMADZU CORPORATION
04540217020249
GS1

1
690558747 *Terms of Use
No description.
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Device Characteristics
Labeling does not contain MRI Safety Information
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No
No
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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?
15963 X-ray image intensifier
A device that converts an x-ray image into a light image, then to an electronic image and finally back to a light-based image of diminished size and increased brightness. It consists of a large evacuated glass envelope with four basic parts: 1) an input phosphor/fluorescent screen; 2) a photocathode; 3) an electrostatic focusing lens; and 4) an accelerating anode and output phosphor/fluorescent screen. This GMDN code includes single, dual and triple field intensifier designs. It is primarily used in fluoroscopic, angiographic, cine-fluorographic x-ray, and digital x-ray applications as it outputs an image small enough to be coupled to cine, television or spot-film cameras.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
JAA System, X-Ray, Fluoroscopic, Image-Intensified
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K012424 000
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Sterilization
No
No
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
daee0af6-abae-434e-a786-c5ae45cda597
May 28, 2025
4
September 16, 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
Yes
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Customer Contact

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No Customer Contact currently defined
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