AeroDR X70

GUDID 04560141946231

KONICA MINOLTA, INC.

Stationary basic diagnostic x-ray system, digital

• Primary Device ID: 04560141946231
• NIH Device Record Key: ec95f464-cc52-4b95-a985-fa985fcd511d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AeroDR X70
• Version Model Number: AACT
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	04560141946231 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121109

FDA Product Code

• KPR: System, X-Ray, Stationary

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: 2018-07-06
• Device Publish Date: 2016-12-15

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