510(k) K843917

FLUOROSCOPIC AUTOMATIC BRIGHTNESS CNTL by Afp Imaging Corp. — Product Code JAA

K843917 is an FDA 510(k) premarket notification submitted by Afp Imaging Corp. for the device "FLUOROSCOPIC AUTOMATIC BRIGHTNESS CNTL". The FDA issued a decision of Substantially Equivalent on January 3, 1985. The device falls under product code JAA (System, X-Ray, Fluoroscopic, Image-Intensified), a Class II device regulated under 21 CFR 892.1650. Afp Imaging Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 3, 1985
Date Received
October 5, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Fluoroscopic, Image-Intensified
Device Class
Class II
Regulation Number
892.1650
Review Panel
RA
Submission Type