Iscreen Vision, Inc.
FDA Regulatory Profile
Iscreen Vision, Inc. has 0 FDA recalls, 4 inspections, 1 510(k) clearance and 0 compliance actions on record.
- Latest inspection
- Sep 28, 2023 · NAI
- Latest 510(k)
- Jan 12, 2011
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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 | 4 | Nov 8, 2026 | Newest record Oct 28, 2026 | Current |
|---|
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
|---|
Recent FDA Inspections
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 3003004358 | Cordova, TN | 4 | Sep 28, 2023 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K102651 | ISCREEN VISION SCREENER | Jan 12, 2011 |