Cleared Traditional

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

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

K230463 is an FDA 510(k) clearance for the NSite Scoliosis Assessment App. Classified as Device, Sensing, Optical Contour (product code LDK).

Submitted by Nsite, Inc. (Menlo Park, US). The FDA issued a Cleared decision on November 15, 2023 after a review of 267 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Nsite, Inc. devices

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
152d slower than avg
Panel avg: 115d · This submission: 267d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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