Bone Suppression Software

GUDID 04560141951433

KONICA MINOLTA, INC.

Basic diagnostic x-ray system application software

• Primary Device ID: 04560141951433
• NIH Device Record Key: 0179f95d-377e-4817-a4ef-14dc52ecfd6d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bone Suppression Software
• Version Model Number: AEVM
• Company DUNS: 692076161
• Company Name: KONICA MINOLTA, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• 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	04560141951433 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240281

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: 2024-07-16
• Device Publish Date: 2024-07-08

Devices Manufactured by KONICA MINOLTA, INC.

• 04560141950887 - P-53: 2024-12-16
• 04560141950894 - P-53: 2024-12-16
• 04560141951419 - CS-7: 2024-12-16
• 04560141951433 - Bone Suppression Software: 2024-07-16
• 04560141951433 - Bone Suppression Software: 2024-07-16
• 04560141950399 - ImagePilot: 2023-07-27
• 04560141950771 - G-59: 2023-06-22
• 04560141950788 - G-60: 2023-06-22
• 04560141950795 - G-22: 2023-06-22