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510(k) K001314

MEDSCOPE by All-Pro Imaging Corp. — Product Code HEX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 2000
Date Received
April 26, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Colposcope (And Colpomicroscope)
Device Class
Class II
Regulation Number
884.1630
Review Panel
OB
Submission Type

Other clearances by All-Pro Imaging Corp.

  • K001321 — ALL-PRO 2010 (May 16, 2000)
  • K991435 — AII-PRO 100 PLUS AND ALL-PRO 200 (May 20, 1999)
  • K911291 — ALL-PRO 100 (July 3, 1991)

Other clearances for product code HEX

  • K233043 — Smart Scope® CX (June 14, 2024)
  • K190187 — Gynescope System (May 8, 2019)
  • K182764 — Biop Digital Colposcope (November 27, 2018)
  • K181034 — Pocket Colposcope System (September 21, 2018)
  • K170446 — LT-300 SD Digital Video Colposcope (May 21, 2017)
  • K161871 — EVA (Enhanced Visual Assessment) System (December 19, 2016)
  • K160341 — Colposcope System (September 14, 2016)
  • K160380 — LT-300 HD (May 13, 2016)
  • K151878 — Video Colposcope (December 1, 2015)
  • K143119 — LT-300 Video Colposcope (December 18, 2014)