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510(k) K011827

ORTELIUS 800 by Orthoscan , Ltd. — Product Code KQX

K011827 is an FDA 510(k) premarket notification submitted by Orthoscan , Ltd. for the device "ORTELIUS 800". The FDA issued a decision of Substantially Equivalent on August 28, 2001. The device falls under product code KQX (Goniometer, Ac-Powered), a Class I device regulated under 21 CFR 888.1500. Orthoscan , Ltd. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 28, 2001
Date Received
June 12, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Goniometer, Ac-Powered
Device Class
Class I
Regulation Number
888.1500
Review Panel
NE
Submission Type

Other clearances by Orthoscan , Ltd.

  • K213113 — Orthoscan Tau Mini C-Arm (October 21, 2021)
  • K183220 — OrthoScan TAU Mini C-Arm (June 21, 2019)
  • K133174 — ORTHOSCAN FD MINI C-ARM (March 28, 2014)
  • K113708 — ORTHOSCAN MOBILE DI MINI C-ARM (January 5, 2012)
  • K051754 — ORTHOSCAN, ORTHOSCAN HD (August 9, 2005)

Other clearances for product code KQX

  • K971079 — INTERLOGICS W-TRACKER AND WRIST WORKS SOFTWARE (July 9, 1997)
  • K962377 — 3D-SPINE (September 3, 1996)
  • K961212 — SPINAL TOUCH (June 12, 1996)
  • K954647 — INCLINOMETER (October 30, 1995)
  • K943929 — DATAGLOVE AND MOVEMENT ANALYSIS SYSTEM (MAS) (May 15, 1995)
  • K945630 — LARGE MUSCLE STRENGTH GAUGE (May 10, 1995)
  • K943898 — SAUNDERS ELECTRONIC INCLINOMETER (November 28, 1994)
  • K940812 — INSIGHT ELECTRONIC ALIGNMENT INDICATOR (November 21, 1994)
  • K925225 — THE BTE VECTOR; ANALYSIS SYSTEM FOR THE LOW BACK (June 27, 1994)
  • K933063 — ISOTECHNOLOGIES BACK TRACKER AND BACK WORKS SOFTWA (January 27, 1994)

FDA data resources