510(k) K771689

DIAL X COLLIMATOR MODEL A&B by Bennett X-Ray Corp. — Product Code IZX

K771689 is an FDA 510(k) premarket notification submitted by Bennett X-Ray Corp. for the device "DIAL X COLLIMATOR MODEL A&B". The FDA issued a decision of Substantially Equivalent on September 14, 1977. The device falls under product code IZX (Collimator, Manual, Radiographic), a Class II device regulated under 21 CFR 892.1610. Bennett X-Ray Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 1977
Date Received
September 6, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Collimator, Manual, Radiographic
Device Class
Class II
Regulation Number
892.1610
Review Panel
RA
Submission Type