510(k) K760569

THREE PHASE X-RAY CONTROLS & HV GENERATORS by Litton Medical Systems — Product Code IZO

K760569 is an FDA 510(k) premarket notification submitted by Litton Medical Systems for the device "THREE PHASE X-RAY CONTROLS & HV GENERATORS". The FDA issued a decision of Substantially Equivalent on September 15, 1976. The device falls under product code IZO (Generator, High-Voltage, X-Ray, Diagnostic), a Class I device regulated under 21 CFR 892.1700. Litton Medical Systems has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 1976
Date Received
September 2, 1976
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