Computational Diagnostics, Inc.
FDA Regulatory Profile
Computational Diagnostics, Inc. has 0 FDA recalls, 6 inspections, 1 510(k) clearance and 0 compliance actions on record.
- Latest inspection
- Aug 28, 2025 · NAI
- Latest 510(k)
- Jan 26, 1996
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Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
|---|
| Recalls | 0 | Nov 4, 2026 (checked Nov 8, 2026, unchanged) | File dated Nov 3, 2026 | Current |
|---|
| 510(k) clearances | 1 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
|---|
| Inspections | 6 | Nov 9, 2026 | Newest record Oct 28, 2026 | Current |
|---|
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
|---|
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|
| Aug 28, 2025 | Pittsburgh, PA | Devices | No Action Indicated (NAI) | 1000221291 |
| Sep 19, 2019 | Pittsburgh, PA | Devices | No Action Indicated (NAI) | 1000221291 |
| Aug 17, 2017 | Pittsburgh, PA | Devices | No Action Indicated (NAI) | 1000221291 |
| Apr 3, 2013 | Pittsburgh, PA | Devices | No Action Indicated (NAI) | 1000221291 |
| Sep 28, 2010 | Pittsburgh, PA | Devices | No Action Indicated (NAI) | 1000221291 |
| Dec 5, 2008 | Pittsburgh, PA | Devices | No Action Indicated (NAI) | 1000221291 |
NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.
FDA-Inspected Facilities
| Facility | Location | Inspections | Latest |
|---|
| FEI 1000221291 | Pittsburgh, PA | 6 | Aug 28, 2025 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K952294 | NEURONET | Jan 26, 1996 |