Contact
by Viz.Al, Inc. 510(k)
Active
510(k) DEN170073
Overview
Contact is a radiological computer-assisted triage and notification software. It is designed to assist in the management of radiological images.
This device is authorized under FDA 510(k) number DEN170073. It is classified as a class 2 medical device under regulation number 892.2080.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA De NovoDENG | NumberDEN170073 | Date13 Feb 2018 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA De Novo Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- QAS
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.2080
- Advisory Committee
- Radiology
- FDA Decision
- DENG De Novo granted
Questions
What is the primary function of the ContaCT software?
ContaCT is a radiological computer-assisted triage and notification software. It is specifically designed to assist healthcare professionals in the management of radiological images.
What is the regulatory status of the ContaCT device?
ContaCT is authorized under FDA 510(k) number DEN170073. It is classified as a class 2 medical device under regulation number 892.2080, which pertains to radiological computer-assisted triage and notification software.
Who is the manufacturer of the ContaCT software?
The ContaCT software is manufactured by Viz.Al, Inc., which is based in San Francisco, California.