510(k) K924445

BA-4 WALL BUCKY AND BA-42 TILTING WALL BUCKY by Control-X, Inc. — Product Code IXY

K924445 is an FDA 510(k) premarket notification submitted by Control-X, Inc. for the device "BA-4 WALL BUCKY AND BA-42 TILTING WALL BUCKY". The FDA issued a decision of Substantially Equivalent on February 19, 1993. The device falls under product code IXY (Holder, Radiographic Cassette, Wall-Mounted), a Class I device regulated under 21 CFR 892.1880. Control-X, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 19, 1993
Date Received
September 1, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Holder, Radiographic Cassette, Wall-Mounted
Device Class
Class I
Regulation Number
892.1880
Review Panel
RA
Submission Type