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510(k) K884292

STRETCHER TABLE by Fischer Imaging Corp. — Product Code KXH

K884292 is an FDA 510(k) premarket notification submitted by Fischer Imaging Corp. for the device "STRETCHER TABLE". The FDA issued a decision of Substantially Equivalent on March 31, 1989. The device falls under product code KXH (Cradle, Patient, Radiologic), a Class I device regulated under 21 CFR 892.1830. Fischer Imaging Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 1989
Date Received
October 12, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cradle, Patient, Radiologic
Device Class
Class I
Regulation Number
892.1830
Review Panel
RA
Submission Type

Other clearances by Fischer Imaging Corp.

  • K042095 — MAMMOTEST (October 29, 2004)
  • K021113 — MAMMOPATH (June 13, 2002)
  • K981414 — LC POSITIONER (July 16, 1998)
  • K973400 — MAMMOTEST ADAPTER DRIVER (November 10, 1997)
  • K964806 — MD-1835 (March 4, 1997)
  • K961207 — EP-X BIPLANE (August 20, 1996)
  • K961022 — TANGENT VI TABLE (May 3, 1996)
  • K950291 — DIGITAL 625HF (March 23, 1995)
  • K945619 — ATHENA HFX (March 23, 1995)
  • K944149 — MICRO X-80 HF (September 16, 1994)

Other clearances for product code KXH

  • K122174 — PEDIATRIC POSITIONER PAD SET (November 16, 2012)
  • K953246 — OCTOROLL (September 29, 1995)
  • K930124 — VARIANT OF OCTOSTOP AND OCTOPAQUE (February 9, 1994)
  • K933134 — SPECTRUM DG-P7000 PEDIATRIC CRADLE (October 7, 1993)
  • K930357 — ACCESSORY TO UNIVERSAL OCTOPAQUE (July 13, 1993)
  • K863890 — MAMM-AIRE (October 14, 1986)
  • K840463 — DIGITAL CRADLE (February 21, 1984)
  • K813561 — SPECTRUM PEDIATRIC CARDLE TABLE (January 29, 1982)

FDA data resources