510(k) K924423

MWX-7440 HIGH SPEED BUCKY by Midwest X-Ray Equipment Co. — Product Code KPX

K924423 is an FDA 510(k) premarket notification submitted by Midwest X-Ray Equipment Co. for the device "MWX-7440 HIGH SPEED BUCKY". The FDA issued a decision of Substantially Equivalent on January 15, 1993. The device falls under product code KPX (Changer, Radiographic Film/Cassette), a Class II device regulated under 21 CFR 892.1860. Midwest X-Ray Equipment Co. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 15, 1993
Date Received
September 1, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Changer, Radiographic Film/Cassette
Device Class
Class II
Regulation Number
892.1860
Review Panel
RA
Submission Type