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510(k) K770335

COLLIMATOR, AUTOMATIC by Litton Medical Systems — Product Code KPW

K770335 is an FDA 510(k) premarket notification submitted by Litton Medical Systems for the device "COLLIMATOR, AUTOMATIC". The FDA issued a decision of Substantially Equivalent on February 28, 1977. The device falls under product code KPW (Device, Beam Limiting, X-Ray, Diagnostic), a Class II device regulated under 21 CFR 892.1610. Litton Medical Systems has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 28, 1977
Date Received
February 18, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Beam Limiting, X-Ray, Diagnostic
Device Class
Class II
Regulation Number
892.1610
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)
  • K770336 — X-RAY TUBE, ROTATING ANODE (March 1, 1977)
  • K770333 — FLUOROSCOPE, C-ARM (March 1, 1977)
  • K770334 — TILTING X-RAY TABLE (March 1, 1977)
  • K760568 — SINGLE PHASE X-RAY CONTROLS & HV GENERATORS (September 15, 1976)
  • K760569 — THREE PHASE X-RAY CONTROLS & HV GENERATORS (September 15, 1976)

Other clearances for product code KPW

  • K093596 — LUMOS, MODEL R 72B (January 12, 2010)
  • K062788 — COLLIMATOR, MODEL M-38 (December 28, 2006)
  • K030487 — R 72 (August 1, 2003)
  • K954310 — BLA-800A (October 18, 1995)
  • K946320 — R 302 (May 11, 1995)
  • K914184 — P2020-8-0 BEAM-LIMITING DEVICE (November 27, 1991)
  • K904587 — DENSICOMP 250 (January 24, 1991)
  • K904044 — TF-63SA (November 29, 1990)
  • K904489 — EUREKA EXTENSION CYLINDERS (October 15, 1990)
  • K820306 — RALCO COLLIMATOR, AUTOMATIC RADIOGRAPHIC (March 5, 1982)

FDA data resources