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510(k) K883155

RASTIX X-RAY TABLE by Bay X-Ray, Inc. — Product Code KXJ

K883155 is an FDA 510(k) premarket notification submitted by Bay X-Ray, Inc. for the device "RASTIX X-RAY TABLE". The FDA issued a decision of Substantially Equivalent on September 6, 1988. The device falls under product code KXJ (Table, Radiologic), a Class II device regulated under 21 CFR 892.1980. Bay X-Ray, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 6, 1988
Date Received
July 26, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table, Radiologic
Device Class
Class II
Regulation Number
892.1980
Review Panel
RA
Submission Type

Other clearances by Bay X-Ray, Inc.

  • K883161 — HIMOBILIX 2N (October 21, 1988)
  • K883160 — CATAPULT BUCKY (KATAPULT BLENDA) (September 8, 1988)
  • K883153 — UNDISTAT WITH EXPLORATOR 35 (UCS 35E) (September 6, 1988)
  • K883162 — TELESTATIX X-RAY TABLE (September 6, 1988)
  • K883154 — SELDIX 325 TWO PULSE GENERATOR/CONTROL (September 6, 1988)

Other clearances for product code KXJ

  • K050190 — APOLLO (March 25, 2005)
  • K963905 — RADIOGRAPHIC ITT TABLE (November 12, 1996)
  • K955414 — XRT 400 (July 24, 1996)
  • K951146 — IMAGING TABLE (May 4, 1995)
  • K950068 — CARBON FIBER COUCH INSERT (April 6, 1995)
  • K950442 — INFRARED EXPOSURE HAND SWITCH (March 31, 1995)
  • K940696 — SYNCRA TILT OPTION FOR ANGIO DIAGNOST 5 (March 16, 1994)
  • K931724 — ELECTROPHYSIOLOGY (EP) TABLE EP 2000 SERIES (June 14, 1993)
  • K926407 — MODEL COLE TAB-2 TABLE W/MODEL COLE SFD-2 SPOTFILM (March 31, 1993)
  • K922098 — CAG-02A (July 27, 1992)

FDA data resources