510(k) K924443

RS-3 UNIVERSAL RADIOGRAPHIC WORKING PLACE by Control-X, Inc. — Product Code IZF

K924443 is an FDA 510(k) premarket notification submitted by Control-X, Inc. for the device "RS-3 UNIVERSAL RADIOGRAPHIC WORKING PLACE". The FDA issued a decision of Substantially Equivalent on February 5, 1993. The device falls under product code IZF (System, X-Ray, Tomographic), a Class II device regulated under 21 CFR 892.1740. Control-X, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 5, 1993
Date Received
September 1, 1992
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