DEVICE: REGIUS MODEL SIGMA2 (04560141936423)

Device Identifier (DI) Information

REGIUS MODEL SIGMA2
A5EU
In Commercial Distribution

KONICA MINOLTA, INC.
04560141936423
GS1

1
692076161 *Terms of Use
No description.
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Device Characteristics

MR Unsafe
No
No
No
Yes
No
No
No
No

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
Computed radiography scanning system An assembly of devices designed to be used with an analogue x-ray system to capture radiographic images and then generate digital x-ray images from them as part of a two-step process for image viewing, storage, or hard-copy printing. It typically consists of an exposure unit with imaging receptor (e.g., a cassette containing a plate), an image reader, a computer console, and a printer. The image is acquired on a photostimulatable substance (e.g., a phosphor screen mounted on a cassette plate) and converted into an electrical analogue signal in a laser scanner; this signal is in turn amplified and converted to a digital signal, which is stored and processed by a computer.
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FDA Product Code

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Product Code Product Code Name
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K120131 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

c6ab770d-8656-441b-b4d4-1d133aa21ec7
February 21, 2019
4
September 19, 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)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
No
No
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Customer Contact

[?]
No Customer Contact currently defined
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