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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 March 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 at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 1977
Date Received
February 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

Other clearances by Litton Medical Systems

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

Other clearances for product code ITY

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

FDA data resources