Cleared Traditional

K230463 - NSite Scoliosis Assessment App (FDA 510(k) Clearance)

K230463 · Nsite, Inc. · Physical Medicine device
Nov 2023
Decision
267d
Days
-
Risk

K230463 is an FDA 510(k) clearance for the NSite Scoliosis Assessment App. This device is classified as a Device, Sensing, Optical Contour.

Submitted by Nsite, Inc. (Menlo Park, US). The FDA issued a Cleared decision on November 15, 2023, 267 days after receiving the submission on February 21, 2023.

This device falls under the Physical Medicine FDA review panel.

Submission Details

510(k) Number K230463 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 2023
Decision Date November 15, 2023
Days to Decision 267 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF

Device Classification

Product Code LDK - Device, Sensing, Optical Contour
Device Class -