510(k) K945731

HFQ HIGH FREQUENCY RADIOGRAPHIC AND FLUROSCOPIC GENERATORS by Bennett X-Ray Corp. — Product Code IZO

K945731 is an FDA 510(k) premarket notification submitted by Bennett X-Ray Corp. for the device "HFQ HIGH FREQUENCY RADIOGRAPHIC AND FLUROSCOPIC GENERATORS". The FDA issued a decision of Substantially Equivalent on February 15, 1995. The device falls under product code IZO (Generator, High-Voltage, X-Ray, Diagnostic), a Class I device regulated under 21 CFR 892.1700. Bennett X-Ray Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 15, 1995
Date Received
November 22, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Generator, High-Voltage, X-Ray, Diagnostic
Device Class
Class I
Regulation Number
892.1700
Review Panel
RA
Submission Type