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510(k) K931563

SPECTRUM MARK I SPECIAL PROCEDURES TABLE by Spectrum X-Ray Corp. — Product Code IXR

K931563 is an FDA 510(k) premarket notification submitted by Spectrum X-Ray Corp. for the device "SPECTRUM MARK I SPECIAL PROCEDURES TABLE". The FDA issued a decision of Substantially Equivalent on August 23, 1993. The device falls under product code IXR (Table, Radiographic, Tilting), a Class II device regulated under 21 CFR 892.1980. Spectrum X-Ray Corp. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 23, 1993
Date Received
March 30, 1993
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 Spectrum X-Ray Corp.

  • K933134 — SPECTRUM DG-P7000 PEDIATRIC CRADLE (October 7, 1993)
  • K870707 — PENTAMAX 1 MODEL B TABLE SYSTEM (May 14, 1987)
  • K834494 — SPECTRUM X-RAY CORP (February 21, 1984)
  • K840463 — DIGITAL CRADLE (February 21, 1984)
  • K827450 — SIMPLAMATIC III (May 19, 1982)
  • K813561 — SPECTRUM PEDIATRIC CARDLE TABLE (January 29, 1982)
  • K791812 — SPECTRUM EMERGENCY & TRAUMA TABLE SYSTEM (November 5, 1979)
  • K791811 — SPECTRUM AUTOMATIC CHEST UNIT MODEL C (October 26, 1979)

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