BriefCase-Quantification

GUDID 07290018052266

BriefCase-Quantification is an Automated Radiological Image Processing Software.

AIDOC MEDICAL LTD

Radiology DICOM image processing application software

• Primary Device ID: 07290018052266
• NIH Device Record Key: 157fa8e2-859a-4988-84bd-c6c39dce6a8c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BriefCase-Quantification
• Version Model Number: BC.QTF.4.x.y
• Company DUNS: 532230094
• Company Name: AIDOC MEDICAL LTD
• 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: false
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290018052266 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230534

FDA Product Code

• QIH: Automated Radiological Image Processing Software

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: 2024-06-12
• Device Publish Date: 2024-06-04

On-Brand Devices [BriefCase-Quantification]

• 07290018052266: BriefCase-Quantification is an Automated Radiological Image Processing Software.
• 07290018052235: BriefCase-Quantification is an Automated Radiological Image Processing Software.