AeroDR P-52

GUDID 04560141944565

KONICA MINOLTA, INC.

Indirect flat panel x-ray detector

• Primary Device ID: 04560141944565
• NIH Device Record Key: 6d32a3fb-f6c8-4e30-9354-49cb28f65d13
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AeroDR P-52
• Version Model Number: A8D7
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	04560141944565 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151465

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: 5
• Public Version Date: 2019-05-07
• Device Publish Date: 2016-09-19

On-Brand Devices [AeroDR P-52]

• 04560141944572: A92H
• 04560141944565: A8D7
• 04560141941694: A6C7