Rapid

Basic Information

• Brand Name: Rapid
• Primary DI: B7671R511
• Version / Model: 5.1.1
• Catalog Number: Rapid
• Company Name: Ischemaview, Inc.
• Labeler DUNS: 079477740
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-05-25
• Public Version: 3
• Public Version Date: 2023-10-18
• Public Version Status: Update
• Public Device Record Key: 532cde37-1a64-4494-b9cb-12f15d07ba84

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
POK	Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer	Radiology	892.2060	2
QAS	Radiological Computer-Assisted Triage And Notification Software	Radiology	892.2080	2
LLZ	System, Image Processing, Radiological	Radiology	892.2050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
41670	Radiological PACS software	An individual software application intended to be installed on a central server as part of a picture archiving and communication system (PACS) to allow storage, retrieval, analysis, and management of radiological images.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B7671R511	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K182130	000
K193087	000
K200760	000
K200941	000