ImagePilot

GUDID 04560141950382

KONICA MINOLTA, INC.

Radiology PACS software

• Primary Device ID: 04560141950382
• NIH Device Record Key: 45e5bdb8-4935-4fc9-9c18-02a7be527678
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ImagePilot
• Version Model Number: V1.94R00E
• 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	04560141950382 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210066

FDA Product Code

• LLZ: System, Image Processing, Radiological

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-03-11
• Device Publish Date: 2022-03-03

On-Brand Devices [ImagePilot]

• 04560141944961: D9MA
• 04560141949492: V1.92R00E
• 04560141949584: V1.93R00E
• 04560141950382: V1.94R00E
• 04560141950399: V1.95