510(k) K925598

BUCKYMATIC AUTOMATIC CHEST FILM CHANGER by Acoma Medical Imaging, Inc. — Product Code KPX

K925598 is an FDA 510(k) premarket notification submitted by Acoma Medical Imaging, Inc. for the device "BUCKYMATIC AUTOMATIC CHEST FILM CHANGER". The FDA issued a decision of Substantially Equivalent on February 1, 1993. The device falls under product code KPX (Changer, Radiographic Film/Cassette), a Class II device regulated under 21 CFR 892.1860. Acoma Medical Imaging, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

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