FDA Inspection
Cardiovascular Imaging Technologies, LLC.Cardiovascular Imaging Technologies, LLC. – FDA Inspection, Oct 5, 2018
Record Details
This FDA Inspection record concerns Cardiovascular Imaging Technologies, LLC., with an inspection on October 5, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 2e72cce7-7227-4004-9b29-c33cee06c20b
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1067868
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.30(g)Design validation - software validation documentation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Cardiovascular Imaging Technologies, LLC.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| March 18, 2024 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 8, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 8, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Cardiovascular Imaging Technologies, LLC.
- FDA Inspection 1233607 - 2024-03-18
- FDA Inspection 843272 - 2013-08-08
- FDA Inspection 610037 - 2009-09-08
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