510(k) K770338

X-RAY CONTROL & X-RAY HV GENERATOR by Litton Medical Systems — Product Code IZO

K770338 is an FDA 510(k) premarket notification submitted by Litton Medical Systems for the device "X-RAY CONTROL & X-RAY HV GENERATOR". The FDA issued a decision of Substantially Equivalent on Mar 1, 1977. 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 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Mar 1, 1977
Date Received
Feb 18, 1977
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
510(k) Exempt

Source: FDA 510(k) database entry for K770338. Report a data issue: hello@regdatalab.com.