REGIUS Cassette

Basic Information

• Brand Name: REGIUS Cassette
• Primary DI: 04560141933361
• Version / Model: A1PJ
• Company Name: KONICA MINOLTA, INC.
• Labeler DUNS: 692076161
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-10-19
• Public Version: 4
• Public Version Date: 2023-02-03
• Public Version Status: Update
• Public Device Record Key: 140e6c4f-a7f1-4f9a-bafb-ba74ff5e0888

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
44823	Digital imaging cassette	A device used in medical imaging applications 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, in the process of producing a digital image of a patient radiation pattern.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04560141933361	GS1

Premarket Submissions

Submission Number	Supplement Number
K103703	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			15cm x 30cm