510(k) K942175

LINEAR TOMOGRAPHIC SYSTEM: PMT 6000 by Continental X-Ray Corp. — Product Code IZF

K942175 is an FDA 510(k) premarket notification submitted by Continental X-Ray Corp. for the device "LINEAR TOMOGRAPHIC SYSTEM: PMT 6000". The FDA issued a decision of Substantially Equivalent on August 17, 1994. The device falls under product code IZF (System, X-Ray, Tomographic), a Class II device regulated under 21 CFR 892.1740. Continental X-Ray Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 17, 1994
Date Received
May 4, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Tomographic
Device Class
Class II
Regulation Number
892.1740
Review Panel
RA
Submission Type