Home / 510(k) Clearances / K770336

510(k) K770336

X-RAY TUBE, ROTATING ANODE by Litton Medical Systems — Product Code ITY

K770336 is an FDA 510(k) premarket notification submitted by Litton Medical Systems for the device "X-RAY TUBE, ROTATING ANODE". The FDA issued a decision of Substantially Equivalent on Mar 1, 1977. The device falls under product code ITY (Assembly, Tube Housing, X-Ray, Diagnostic), a Class I device regulated under 21 CFR 892.1760. 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
Assembly, Tube Housing, X-Ray, Diagnostic
Device Class
Class I
Regulation Number
892.1760
Review Panel
RA
Submission Type
510(k) Exempt

Other clearances by Litton Medical Systems

  • K770338 — X-RAY CONTROL & X-RAY HV GENERATOR (Mar 1, 1977)
  • K770333 — FLUOROSCOPE, C-ARM (Mar 1, 1977)
  • K770334 — TILTING X-RAY TABLE (Mar 1, 1977)
  • K770337 — FLUOROSCOPIC ASSEMBLY, IMAGE INTENS. (Mar 1, 1977)
  • K770335 — COLLIMATOR, AUTOMATIC (Feb 28, 1977)
  • K760569 — THREE PHASE X-RAY CONTROLS & HV GENERATORS (Sep 15, 1976)
  • K760568 — SINGLE PHASE X-RAY CONTROLS & HV GENERATORS (Sep 15, 1976)

Other clearances for product code ITY

  • K000052 — X-RAY MONOBLOCK, MONOBLOCK XRS-60-330 (Feb 10, 2000)
  • K933162 — MRX-750 (Oct 7, 1993)
  • K923094 — MOLYBDENUM (Mar 4, 1993)
  • K923141 — PHILIPS PRE-FILTER OPTION (Jan 21, 1993)
  • K921129 — MRX-700 (Oct 5, 1992)
  • K921130 — MRX-865 (Sep 10, 1992)
  • K921316 — MG-1001 TUBE HOUSING ASSEMBLY (Jun 22, 1992)
  • K920731 — X-RAY TUBE ASSEMBLY CIRCLEX1.2UG (May 29, 1992)
  • K920723 — HIGH SPEED ROTATION STARTER SA-40 (Apr 27, 1992)
  • K920724 — HIGH SPEED ROTATION STARTER SA-50 (Apr 27, 1992)

FDA data resources

Source: FDA 510(k) database entry for K770336. Report a data issue: hello@regdatalab.com.