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510(k) K770334

TILTING X-RAY TABLE by Litton Medical Systems — Product Code IXR

K770334 is an FDA 510(k) premarket notification submitted by Litton Medical Systems for the device "TILTING X-RAY TABLE". The FDA issued a decision of Substantially Equivalent on March 1, 1977. The device falls under product code IXR (Table, Radiographic, Tilting), a Class II device regulated under 21 CFR 892.1980. 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
Table, Radiographic, Tilting
Device Class
Class II
Regulation Number
892.1980
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)
  • K770336 — X-RAY TUBE, ROTATING ANODE (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 IXR

  • K000412 — VISION R/F TILTING TABLE (April 24, 2000)
  • K973039 — LEGACY/LEGACY-D TABLE (October 16, 1997)
  • K971128 — CAP-35B III/CINE 275 (April 28, 1997)
  • K970640 — PHILIPS EASY DIAGNOST (March 21, 1997)
  • K965105 — ELECTROPHYSIOLOGY TILT TABLE MODEL #9660 (January 30, 1997)
  • K965096 — FLUOROVIEW SERIES FLUOROSCOPIC TABLES (January 27, 1997)
  • K963851 — TILTING RADIOGRAPHIC TABLE (REMOTE) (January 23, 1997)
  • K961022 — TANGENT VI TABLE (May 3, 1996)
  • K954356 — COMPAX 90/15E (October 7, 1995)
  • K953556 — VACS TABLE, 9650 (September 26, 1995)

FDA data resources