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510(k) K761339

RADIAL TRAVEL SPEC. PROCEDURES TABLE by Xre Corp. — Product Code IZZ

K761339 is an FDA 510(k) premarket notification submitted by Xre Corp. for the device "RADIAL TRAVEL SPEC. PROCEDURES TABLE". The FDA issued a decision of Substantially Equivalent on January 5, 1977. The device falls under product code IZZ (Table, Radiographic, Non-Tilting, Powered), a Class II device regulated under 21 CFR 892.1980. Xre Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 5, 1977
Date Received
December 27, 1976
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 Xre Corp.

  • K973744 — UNICATH SP BI-PLANE (MODEL M269 & M289) (December 29, 1997)
  • K961193 — FULL FRAME ZOOM SYSTEM (June 17, 1996)
  • K960998 — XRE COLLIMATOR (April 3, 1996)
  • K945449 — UNICATH LLU ANGIOGRAPHIC SYSTEM (February 27, 1995)
  • K936002 — CINEMAC QAS (September 9, 1994)
  • K933460 — DVFX, MODEL M256 (April 7, 1994)
  • K924828 — BI-N (December 17, 1992)
  • K923654 — POLY DIAGNOST CDX (November 20, 1992)
  • K913685 — UNICATH EP. (November 7, 1991)
  • K912416 — ANGIOGRAPHIC OR FLUOROSCOPIC X-RAY SYSTEM (August 28, 1991)

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