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510(k) K926082

CARDIAC STRESS TABLE, 056-180/UNIV ROLL STRESS ATT by Biodan Medical Systems, Ltd. — Product Code IZI

K926082 is an FDA 510(k) premarket notification submitted by Biodan Medical Systems, Ltd. for the device "CARDIAC STRESS TABLE, 056-180/UNIV ROLL STRESS ATT". The FDA issued a decision of Substantially Equivalent on December 30, 1992. The device falls under product code IZI (System, X-Ray, Angiographic), a Class II device regulated under 21 CFR 892.1600. Biodan Medical Systems, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 30, 1992
Date Received
December 1, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Angiographic
Device Class
Class II
Regulation Number
892.1600
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)
  • 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)
  • K922772 — TWO POSITION ROLL-UP BACK ATTACHMENT CHAIR (July 13, 1992)

Other clearances for product code IZI

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  • K253181 — SURGIMAGE SIM 1000H Fluorescence Imaging Platform (May 13, 2026)
  • K243645 — IC-Flow™ Imaging System 2.0 (September 22, 2025)
  • K243077 — Affirm 800 (June 27, 2025)
  • K231986 — Modus IR (March 25, 2024)
  • K234090 — EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004) (March 20, 2024)
  • K231075 — Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option) (June 20, 2023)
  • K230727 — SPY Portable Handheld Imaging (SPY-PHI) System (June 5, 2023)
  • K222240 — EXPLORER AIR® II (February 28, 2023)
  • K214097 — Explorer Air II (February 25, 2022)

FDA data resources