Ultrasound System SONIMAGE MX1

GUDID 04560141947016

KONICA MINOLTA, INC.

General-purpose ultrasound imaging system

• Primary Device ID: 04560141947016
• NIH Device Record Key: c2ac9b03-8203-42b7-8ed4-71f4741f66d2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ultrasound System SONIMAGE MX1
• Version Model Number: AAK9
• 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	04560141947016 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180084

FDA Product Code

• IYO: System, Imaging, Pulsed Echo, Ultrasonic

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: 2018-07-12
• Device Publish Date: 2018-06-11

On-Brand Devices [Ultrasound System SONIMAGE MX1]

• 04560141947016: AAK9
• 04560141950092: ADRH