MEDWS

GUDID 03665587000163

MED.E.COM

Diagnostic x-ray digital imaging system workstation application software

• Primary Device ID: 03665587000163
• NIH Device Record Key: 490390d2-6df5-41f0-b339-497510866052
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MEDWS
• Version Model Number: 7.6
• Company DUNS: 393382168
• Company Name: MED.E.COM
• 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: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	03665587000163 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132684

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: 2025-11-28
• Device Publish Date: 2025-11-20

On-Brand Devices [MEDWS]

• 03665587000002: 4.15
• 03665587000026: 4.17
• 03665587000033: 4.18
• 03665587000057: 5.0
• 03665587000064: 5.2
• 03665587000071: 5.4
• 03665587000088: 5.6
• 03665587000095: 6.1
• 03665587000019: 4.14
• 03665587000149: 7.4
• 03665587000163: 7.6
• 03665587000156: 7.5