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510(k) K903921

MTE-T RADIOGRPHIC/TOMOGRAPHIC ELEVATING TABLE by Imt America, Inc. — Product Code IZZ

K903921 is an FDA 510(k) premarket notification submitted by Imt America, Inc. for the device "MTE-T RADIOGRPHIC/TOMOGRAPHIC ELEVATING TABLE". The FDA issued a decision of Substantially Equivalent on December 4, 1990. The device falls under product code IZZ (Table, Radiographic, Non-Tilting, Powered), 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
December 4, 1990
Date Received
August 24, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table, Radiographic, Non-Tilting, Powered
Device Class
Class II
Regulation Number
892.1980
Review Panel
RA
Submission Type

Other clearances by Imt America, Inc.

  • K901654 — MTT 90 UNIVERSAL REMOTE-CONTROLLED X-RAY TABLE (November 23, 1990)
  • K903422 — MT-15 RADIOGRAPHIC/FLUOROSCOPIC TILT TABLE (September 4, 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 IZZ

  • K971452 — MULTIX TOP/PRO RADIOGRAPHIC X-RAY TABLE (May 14, 1997)
  • K952701 — MED-TRON SPECT IMAGING TABLE (July 6, 1995)
  • K951315 — CATHETERIZATION TABLE KS-60 (May 11, 1995)
  • K951053 — ANGIOREX CAT-350B (April 6, 1995)
  • K943926 — RAPIDO 2000 AUTOMATIC RADIOGRAPHIC TABLE (November 28, 1994)
  • K930273 — ALPHA (July 13, 1993)
  • K924444 — B-4 FOUR-WAY RADIOGRAPHIC TABLE (February 5, 1993)
  • K925174 — SHIMADZU RADIOGRAPHIC TABLE BK-100 (November 27, 1992)
  • K921501 — DELUXE C ARM RADIOLOGICAL TABLE, MODEL #056-004 (May 15, 1992)
  • K920732 — CATHERIZATION KS-50 (April 16, 1992)

FDA data resources