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510(k) K923792

QUANTEC SPINAL MEASUEMENT SYSTEM by Quantec Image Processing , Ltd. — Product Code LDK

K923792 is an FDA 510(k) premarket notification submitted by Quantec Image Processing , Ltd. for the device "QUANTEC SPINAL MEASUEMENT SYSTEM". The FDA issued a decision of Substantially Equivalent on April 20, 1994. The device falls under product code LDK (Device, Sensing, Optical Contour), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 20, 1994
Date Received
July 28, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Sensing, Optical Contour
Device Class
Class U
Regulation Number
Review Panel
PM
Submission Type

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FDA data resources