FDA Inspection
Image Diagnostics, Inc.Image Diagnostics, Inc. – FDA Inspection, Apr 18, 2024
Record Details
This FDA Inspection record concerns Image Diagnostics, Inc., with an inspection on April 18, 2024, issued by the Center for Devices and Radiological Health, covering devices.
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ID · d3ef7a46-7924-441f-95dd-18e237c7f623
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1236226
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.181DMR - not or inadequately maintained
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Other FDA inspections of Image Diagnostics, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| October 16, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 6, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 10, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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