Ultrasound System SONIMAGE HS2

GUDID 04560141949348

KONICA MINOLTA, INC.

General-purpose ultrasound imaging system

• Primary Device ID: 04560141949348
• NIH Device Record Key: 89ec72cd-aaac-4eea-a013-81db624699a7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ultrasound System SONIMAGE HS2
• Version Model Number: ADDV
• 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	04560141949348 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182153

FDA Product Code

• IYN: System, Imaging, Pulsed Doppler, 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: 2020-04-14
• Device Publish Date: 2020-04-06

On-Brand Devices [Ultrasound System SONIMAGE HS2]

• 04560141949355: ADDW
• 04560141949348: ADDV