P-75

GUDID 04560141949294

KONICA MINOLTA, INC.

Indirect flat panel x-ray detector

• Primary Device ID: 04560141949294
• NIH Device Record Key: ecfd5bd3-ca58-451b-894f-42f031804af1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: P-75
• Version Model Number: ADA6
• 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

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Device Identifiers

Device Issuing Agency	Device ID
GS1	04560141949294 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210619

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: 2
• Public Version Date: 2022-11-25
• Device Publish Date: 2022-05-27

On-Brand Devices [P-75]

• 04560141945807: A9YH
• 04560141945784: A9YT
• 04560141949294: ADA6