Linear Tomographic System: PMT 6000
FDA 510(k) K942175 · Continental X-Ray Corp.
510(k) numberK942175
Submission
- Device name
- Linear Tomographic System: PMT 6000
- Applicant
- Continental X-Ray Corp.
Broadview, IL, US - Received
- May 4, 1994
- Decision date
- August 17, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Linear Tomographic System: PMT 6000 cleared by the FDA?
Linear Tomographic System: PMT 6000 (K942175) received a 510(k) decision of Substantially Equivalent on August 17, 1994, 105 days after the submission was received.
What is the product code of K942175?
The FDA product code is IZF – System, X-Ray, Tomographic, a Class II (moderate risk) device regulated under 21 CFR 892.1740.