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510(k) K834494

SPECTRUM X-RAY CORP by Spectrum X-Ray Corp. — Product Code IZZ

K834494 is an FDA 510(k) premarket notification submitted by Spectrum X-Ray Corp. for the device "SPECTRUM X-RAY CORP". The FDA issued a decision of Substantially Equivalent on February 21, 1984. The device falls under product code IZZ (Table, Radiographic, Non-Tilting, Powered), 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
February 21, 1984
Date Received
December 14, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table, Radiographic, Non-Tilting, Powered
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)
  • K931563 — SPECTRUM MARK I SPECIAL PROCEDURES TABLE (August 23, 1993)
  • K870707 — PENTAMAX 1 MODEL B TABLE SYSTEM (May 14, 1987)
  • 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 IZZ

  • K971452 — MULTIX TOP/PRO RADIOGRAPHIC X-RAY TABLE (May 14, 1997)
  • K952701 — MED-TRON SPECT IMAGING TABLE (July 6, 1995)
  • K951315 — CATHETERIZATION TABLE KS-60 (May 11, 1995)
  • K951053 — ANGIOREX CAT-350B (April 6, 1995)
  • K943926 — RAPIDO 2000 AUTOMATIC RADIOGRAPHIC TABLE (November 28, 1994)
  • K930273 — ALPHA (July 13, 1993)
  • K924444 — B-4 FOUR-WAY RADIOGRAPHIC TABLE (February 5, 1993)
  • K925174 — SHIMADZU RADIOGRAPHIC TABLE BK-100 (November 27, 1992)
  • K921501 — DELUXE C ARM RADIOLOGICAL TABLE, MODEL #056-004 (May 15, 1992)
  • K920732 — CATHERIZATION KS-50 (April 16, 1992)

FDA data resources