REGIUS Cassette

GUDID 04560141933361

KONICA MINOLTA, INC.

Digital imaging cassette

• Primary Device ID: 04560141933361
• NIH Device Record Key: 140e6c4f-a7f1-4f9a-bafb-ba74ff5e0888
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: REGIUS Cassette
• Version Model Number: A1PJ
• Company DUNS: 692076161
• Company Name: KONICA MINOLTA, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	04560141933361 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103703

FDA Product Code

• MQB: Solid State X-Ray Imager (Flat Panel/Digital Imager)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-10-29
• Device Publish Date: 2016-10-19

On-Brand Devices [REGIUS Cassette]

• 04560141933743: A1PH
• 04560141933736: A1PG
• 04560141933361: A1PJ
• 04560141933248: A3P6
• 04560141933231: A3P5
• 04560141933224: A3P4
• 04560141933217: A3P3
• 04560141933200: A3P1
• 04560141928411: E2LT
• 04560141928381: E2F7
• 04560141928367: E2E3
• 04560141928350: A2RS
• 04560141928329: A2NE
• 04560141928305: A1GU
• 04560141928282: A2VX
• 04560141928268: A2TC