Rapid Rapid

GUDID B7671R512

ISCHEMAVIEW, INC.

Radiology PACS software

• Primary Device ID: B7671R512
• NIH Device Record Key: 9b8d71f7-5ae7-4429-8317-bef3b20e5f67
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rapid
• Version Model Number: 5.1.2
• Catalog Number: Rapid
• Company DUNS: 079477740
• Company Name: ISCHEMAVIEW, 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: true
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B7671R512 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182130

FDA Product Code

• POK: Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer

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: 2022-06-02
• Device Publish Date: 2022-05-25

On-Brand Devices [Rapid]

• B761RAPID48302: RAPID is a Platform for brain image analysis.
• B761RAPID50210: Rapid
• B761RAPID5020: 5.0.2
• B761RAPID5010: 5.0.1
• B761RAPID500: Rapid
• B761RAPID49101: Rapid
• B7671R5030: 5.0.3
• B761RAPID510: 5.1
• B7671R522: Rapid System Update
• B7671R521: 5.2.2
• B7671R520: 5.2.0
• B7671R512: 5.1.2
• B7671R511: 5.1.1
• B7615511: Rapid System Update
• B761R591: Rapid System Update
• B761R5701: Rapid System Update
• B761R60: Rapid Platform plus cleared indications for Rapid version 6.x