DEVICE: REGIUS Cassette/Plate (04560141930933)

Device Identifier (DI) Information

REGIUS Cassette/Plate
KCTC
In Commercial Distribution

KONICA MINOLTA, INC.
04560141930933
GS1

1
692076161 *Terms of Use
No description.
CLOSE

Device Characteristics

MR Unsafe
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?
44824 Digital imaging cassette/phosphor plate
A device that includes both a digital imaging cassette and a phosphor plate (also known as screen) intended to receive radiation by a diagnostic x-ray system, to record a patient radiation pattern during a non-dental procedure. The device is then transferred, with the cassette shielding the plate from environmental light, to a computed radiography (CR) scanner for insertion to produce the digital image of the patient. This is a reusable device.
Active false
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K092717 000
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: 18cm x 24cm
CLOSE

Device Record Status

b603062a-9f0e-4fe2-adc5-f214ee8cdef3
June 19, 2024
6
September 19, 2016
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
No
Yes
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
CLOSE