Home / 510(k) Clearances / K080859

510(k) K080859

DRF 4343 by Villa Sistemi Medicali S.P.A. — Product Code JAA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 4, 2008
Date Received
March 27, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Fluoroscopic, Image-Intensified
Device Class
Class II
Regulation Number
892.1650
Review Panel
RA
Submission Type

Other clearances by Villa Sistemi Medicali S.P.A.

  • K180601 — Rotograph Prime 3D (under Trade mark Villa Sistemi Medicali), I-MAX 3D (under Tr (November 2, 2018)
  • K162190 — Rotograph Prime (under trade mark Villa Sistemi Medicali), I-MAX (under trade ma (July 6, 2017)
  • K130109 — ENDOGRAPH DC (August 1, 2013)
  • K111152 — ROTOGRAPH EVO 3D (July 22, 2011)
  • K090749 — ROOGRAPH EVO, MODEL 9307XY11Z1, ROTOGRAPH EVO D, MODEL 9307XY1191 (May 18, 2009)
  • K050190 — APOLLO (March 25, 2005)
  • K030634 — ENDOS DC (July 21, 2003)
  • K030185 — ENDOS AC/ACP (March 11, 2003)
  • K002432 — STRATO X (September 1, 2000)
  • K000412 — VISION R/F TILTING TABLE (April 24, 2000)

Other clearances for product code JAA

  • K251650 — Insight Enhanced™ DRF (EN-1002-01) (September 16, 2025)
  • K242488 — Soteria E-View (January 6, 2025)
  • K242948 — Adora DRFi (04550010) (December 23, 2024)
  • K233380 — TRIDENT Mobile Fluoroscopy System (June 26, 2024)
  • K233945 — ProxiDiagnost N90 / Precision CRF (706110, 706400) (January 11, 2024)
  • K232910 — CombiDiagnost R90 (October 19, 2023)
  • K232526 — XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5 (September 12, 2023)
  • K220871 — Nautilus (April 18, 2022)
  • K212890 — Nyquist.IQ (December 13, 2021)
  • K212837 — ProxiDiagnost N90 (September 21, 2021)