FDA Inspection
iCAD, Inc.iCAD, Inc. – FDA Inspection, Jul 2, 2015
Record Details
This FDA Inspection record concerns iCAD, Inc., with an inspection on July 2, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- iCAD, Inc.
- Inspection Date
- July 2, 2015
- Product Type
- Devices
View Company Profile
ID · ac5a88a6-2f7a-472f-a5b9-188427706ae6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 935201
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
1- 21 CFR 820.30(g)Design validation - user needs and intended uses
Full citation text and observation details available on the Dashboard.
Other FDA inspections of iCAD, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| May 25, 2021 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 7, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 19, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 18, 2009 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for iCAD, Inc.
- FDA Inspection 1146145 - 2021-05-25
- FDA Inspection 830427 - 2013-05-07
- FDA Inspection 721926 - 2011-04-19
- FDA Inspection 571386 - 2009-03-18
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