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510(k) K230463

NSite Scoliosis Assessment App by Nsite, Inc. — Product Code LDK

K230463 is an FDA 510(k) premarket notification submitted by Nsite, Inc. for the device "NSite Scoliosis Assessment App". The FDA issued a decision of Substantially Equivalent on November 15, 2023. The device falls under product code LDK (Device, Sensing, Optical Contour), a Class U device.

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: November 15, 2023
Date Received: February 21, 2023
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