Aztech 65 with CCD (Computer Controlled Density) Timer
FDA 510(k) K950667 · Chicago X-Ray Systems, Inc.
510(k) numberK950667
Submission
- Device name
- Aztech 65 with CCD (Computer Controlled Density) Timer
- Applicant
- Chicago X-Ray Systems, Inc.
Wheeling, IL, US - Received
- February 13, 1995
- Decision date
- April 6, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Aztech 65 with CCD (Computer Controlled Density) Timer cleared by the FDA?
Aztech 65 with CCD (Computer Controlled Density) Timer (K950667) received a 510(k) decision of Substantially Equivalent on April 6, 1995, 52 days after the submission was received.
What is the product code of K950667?
The FDA product code is EAP – Unit, X-Ray, Intraoral, a Class II (moderate risk) device regulated under 21 CFR 872.1810.