REGIUS Cassette/Plate

Basic Information

• Brand Name: REGIUS Cassette/Plate
• Primary DI: 04560141922792
• Version / Model: KCLU
• Company Name: KONICA MINOLTA, INC.
• Labeler DUNS: 692076161
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-19
• Public Version: 5
• Public Version Date: 2023-04-04
• Public Version Status: Update
• Public Device Record Key: 9134873c-f5c7-4359-9e94-0da5c4dc1aa6

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	892.1680	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44824	Digital imaging cassette/storage phosphor screen, basic diagnostic x-ray	A combination device for medical imaging applications that consists of a cassette used to hold and shield an attached storage phosphor screen from exposure to room light during transport and insertion into a diagnostic imaging x-ray system, and a computed radiography scanner. The photostimulatable storage phosphor screen is exposed to radiation by the x-ray system to record a patient radiation pattern. The cassette is then loaded into a laser scanner capable of reading the latent image formed on the storage phosphor screen to produce a digital image.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04560141922792	GS1

Premarket Submissions

Submission Number	Supplement Number
K092717	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			14" x 14"