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510(k) K883153

UNDISTAT WITH EXPLORATOR 35 (UCS 35E) by Bay X-Ray, Inc. — Product Code IXR

K883153 is an FDA 510(k) premarket notification submitted by Bay X-Ray, Inc. for the device "UNDISTAT WITH EXPLORATOR 35 (UCS 35E)". The FDA issued a decision of Substantially Equivalent on September 6, 1988. The device falls under product code IXR (Table, Radiographic, Tilting), 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, Radiographic, Tilting
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)
  • K883155 — RASTIX X-RAY TABLE (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 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