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510(k) K162190

Rotograph Prime (under trade mark Villa Sistemi Medicali), I-MAX (under trade mark Owandy Radiology) by Villa Sistemi Medicali S.P.A. — Product Code MUH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 6, 2017
Date Received
August 4, 2016
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Extraoral Source, Digital
Device Class
Class II
Regulation Number
872.1800
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)
  • 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)
  • K080859 — DRF 4343 (June 4, 2008)
  • 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)

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