NeuroDR— 510(k) K262134
Substantially EquivalentDeep Reasoning Ai, Inc.
FDA 510(k) clearance K262134 for NeuroDR, Substantially Equivalent on 2026-10-07. Applicant: Deep Reasoning Ai, Inc.. Device class: 2.
Summary
NeuroDR is software from Deep Reasoning Ai, filed under QIH, automated radiological image processing software. Beyond the "Neuro" in the name, the record doesn't describe the anatomy, modality, or outputs.
Class II, 21 CFR 892.2050. The Radiology panel reviewed it as a Traditional 510(k).
Deep Reasoning Ai filed from Sarasota, Florida. Review took 104 days (June 25 to October 7, 2026).
Clearance details
- Applicant
- Deep Reasoning Ai, Inc.
- Product code
- Product 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
- Sarasota, FL, US
Recent devices under product code QIH
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