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510(k) K921501

DELUXE C ARM RADIOLOGICAL TABLE, MODEL #056-004 by Biodan Medical Systems, Ltd. — Product Code IZZ

K921501 is an FDA 510(k) premarket notification submitted by Biodan Medical Systems, Ltd. for the device "DELUXE C ARM RADIOLOGICAL TABLE, MODEL #056-004". The FDA issued a decision of Substantially Equivalent on May 15, 1992. The device falls under product code IZZ (Table, Radiographic, Non-Tilting, Powered), a Class II device regulated under 21 CFR 892.1980. Biodan Medical Systems, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 1992
Date Received
March 31, 1992
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 Biodan Medical Systems, Ltd.

  • K932153 — THYROID UPTAKE SYSTEM & ATOMLAB 950 MED. SPECTROME (September 7, 1993)
  • K930261 — RTM REHABILITATION TREADMILL, MODEL #945-200 (May 26, 1993)
  • K930262 — TREATMENT TABLE, MODEL #825-100 (March 29, 1993)
  • K930259 — TRACTION TABLE MODEL #825-200 (March 24, 1993)
  • K926083 — NUCLEAR PATIENT SANNING TABLES, VARIOUS TYPES (February 12, 1993)
  • K926082 — CARDIAC STRESS TABLE, 056-180/UNIV ROLL STRESS ATT (December 30, 1992)
  • K922591 — UROLOGICAL C-ARM TABLE, MODEL #056-450 (November 27, 1992)
  • K922605 — TRENDELENBURG ULTRASOUND TABLE, MODEL # 056-603 (October 20, 1992)
  • K922604 — DELUXE ADJUSTABLE HEIGHT ULTRASOUND TABLE (October 20, 1992)
  • K923350 — CLOSED CHAIN ATTACHMENT, MODEL #820-520 (July 23, 1992)

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)
  • K920732 — CATHERIZATION KS-50 (April 16, 1992)
  • K915413 — CAT-250B (December 19, 1991)

FDA data resources