Image Analysis, Inc.
Image Analysis, Inc. has 0 FDA recalls, 1 inspection, 10 510(k) clearances and 0 compliance actions on record.
- Latest inspection
- Aug 17, 2011 · NAI
- Latest 510(k)
- May 17, 2017
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Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Oct 23, 2026 | Not stated | Current |
| 510(k) clearances | 10 | Oct 4, 2026 | Not stated | Current |
| Inspections | 1 | Oct 26, 2026 | Not stated | Current |
| Compliance actions | 0 | Oct 23, 2026 | Not stated | Current |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Aug 17, 2011 | Columbia, KY | Devices | No Action Indicated (NAI) | 2027364 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K161601 | Dynamika | May 17, 2017 |
| K040782 | N-VIVO CALCIUM SCORE ON IA CHASSIS RELEASE, MODEL RELEASE X.XX | Jul 13, 2004 |
| K031991 | DXAVIEW SPINE AND HIP, MODEL QCT-3D PLUS | Jul 30, 2003 |
| K992246 | QCT BONE MINERAL ANALYSIS SOFTWARE | Sep 3, 1999 |
| K952060 | QCT-BONE MINERAL ANALYSIS SOFTWARE OR OCT-BMD OPTION OR OCT-5000 | Jun 5, 1995 |
| K941127 | QCT-BONE MINERAL ANALYSIS SOFTWARE | May 11, 1995 |
| K941126 | QCT-BONE MINERAL ANALYSIS PHANTOM | May 3, 1995 |
| K891931 | QCT-LUNG NODULE (TM) ANALYSIS PACKAGE | May 18, 1989 |
| K852510 | COMPUTED TOMOGRAPHY COUCH PAD FOR MIN ANALYSIS | Oct 18, 1985 |
| K852509 | QCT-BONE MINERAL PHANTOM | Oct 18, 1985 |