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510(k) K840463

DIGITAL CRADLE by Spectrum X-Ray Corp. — Product Code KXH

K840463 is an FDA 510(k) premarket notification submitted by Spectrum X-Ray Corp. for the device "DIGITAL CRADLE". The FDA issued a decision of Substantially Equivalent on February 21, 1984. The device falls under product code KXH (Cradle, Patient, Radiologic), a Class I device regulated under 21 CFR 892.1830. Spectrum X-Ray Corp. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 21, 1984
Date Received
February 2, 1984
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 Spectrum X-Ray Corp.

  • K933134 — SPECTRUM DG-P7000 PEDIATRIC CRADLE (October 7, 1993)
  • K931563 — SPECTRUM MARK I SPECIAL PROCEDURES TABLE (August 23, 1993)
  • K870707 — PENTAMAX 1 MODEL B TABLE SYSTEM (May 14, 1987)
  • K834494 — SPECTRUM X-RAY CORP (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 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)
  • K884292 — STRETCHER TABLE (March 31, 1989)
  • K863890 — MAMM-AIRE (October 14, 1986)
  • K813561 — SPECTRUM PEDIATRIC CARDLE TABLE (January 29, 1982)

FDA data resources