ReVISION 2— 510(k) K251417
Substantially EquivalentArgus Cognitive, Inc.
FDA 510(k) clearance K251417 for ReVISION 2, Substantially Equivalent on 2026-09-09. Applicant: Argus Cognitive, Inc.. Device class: 2.
Summary
ReVISION 2 is software from Argus Cognitive, filed under QIH, automated radiological image processing software. The record doesn't describe what the software does, and the "2" suggests a second version of an earlier product.
Class II, 21 CFR 892.2050. The Radiology panel reviewed it as a Traditional 510(k).
The timeline is the story here: 490 days, from May 7, 2025 to September 9, 2026. That's more than five times FDA's 90-day goal. A clock this long almost always means one or more long holds while the applicant generated data FDA asked for. Argus Cognitive filed from Hanover, New Hampshire.
Clearance details
- Applicant
- Argus Cognitive, Inc.
- Product code
- Code QIH
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hanover, NH, US
Recent devices under product code QIH
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