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510(k) K211623

THD Procto Software System by Thd Spa — Product Code IYO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 2021
Date Received
May 26, 2021
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Imaging, Pulsed Echo, Ultrasonic
Device Class
Class II
Regulation Number
892.1560
Review Panel
RA
Submission Type

Other clearances by Thd Spa

  • K193512 — THD Procto Software System (January 26, 2020)
  • K180135 — THD Anopress with THD SensyProbe (March 8, 2018)
  • K161785 — THD ANOPRESS (March 14, 2017)
  • K141657 — THD REVOLUTION (February 24, 2015)
  • K133687 — THD N-ANO ANOSCOPE (December 11, 2013)
  • K121135 — THD ANOSCOPE, PROCTOSCOPE, RECTOSCOPE, RECTOSCOPE AND LIGHT-SCOPE (June 1, 2012)
  • K103647 — THD DISPOSABLE ANOSCOPES, PROCTOSCOPES AND RECTOSCOPES (March 1, 2011)
  • K093497 — THD BANDY (July 15, 2010)
  • K091490 — FAMILY OF THD DISPOSABLE ANOSCOPES/PROCTOSCOPES/RECTOSCOPES (June 11, 2009)
  • K090009 — THD SLIDE ONE (January 28, 2009)

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