Linear FR Tomographic System: 0MT 8000, Model No. 6681.270
FDA 510(k) K950571 · Continental X-Ray Corp.
510(k) numberK950571
Submission
- Device name
- Linear FR Tomographic System: 0MT 8000, Model No. 6681.270
- Applicant
- Continental X-Ray Corp.
Broadview, IL, US - Received
- January 31, 1995
- Decision date
- March 31, 1995
- 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 FR Tomographic System: 0MT 8000, Model No. 6681.270 cleared by the FDA?
Linear FR Tomographic System: 0MT 8000, Model No. 6681.270 (K950571) received a 510(k) decision of Substantially Equivalent on March 31, 1995, 59 days after the submission was received.
What is the product code of K950571?
The FDA product code is IZF – System, X-Ray, Tomographic, a Class II (moderate risk) device regulated under 21 CFR 892.1740.