FDA Inspection
MedImage, Inc.MedImage, Inc. – FDA Inspection, Nov 2, 2017
Record Details
This FDA Inspection record concerns MedImage, Inc., with an inspection on November 2, 2017, issued by the Center for Devices and Radiological Health, covering devices.
- Person
- Amy S. Graf (Issuing Officer)
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ID · e22bc5c1-c288-4e14-bbb2-6267b64f1855
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1030952
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
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Other FDA inspections of MedImage, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| November 14, 2024 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| December 22, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| April 23, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for MedImage, Inc.
- FDA Inspection 1256107 - 2024-11-14
- FDA Inspection 907723 - 2014-12-22
- FDA Inspection 828568 - 2013-04-23
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