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510(k) K903422

MT-15 RADIOGRAPHIC/FLUOROSCOPIC TILT TABLE by Imt America, Inc. — Product Code IXR

K903422 is an FDA 510(k) premarket notification submitted by Imt America, Inc. for the device "MT-15 RADIOGRAPHIC/FLUOROSCOPIC TILT TABLE". The FDA issued a decision of Substantially Equivalent on September 4, 1990. The device falls under product code IXR (Table, Radiographic, Tilting), a Class II device regulated under 21 CFR 892.1980. Imt America, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 4, 1990
Date Received
July 31, 1990
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 Imt America, Inc.

  • K903921 — MTE-T RADIOGRPHIC/TOMOGRAPHIC ELEVATING TABLE (December 4, 1990)
  • K901654 — MTT 90 UNIVERSAL REMOTE-CONTROLLED X-RAY TABLE (November 23, 1990)
  • K900193 — MTHF-9R MOBIL C-ARM IMAGE INTENSIFIER UNIT (May 9, 1990)
  • K900194 — MTHF-9S MOBIL C-ARM IMAGE INTENSIFIER UNIT (May 7, 1990)

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)
  • K953557 — SURGICAL C-ARM TABLE, 9610 (September 26, 1995)

FDA data resources