510(k) · Cleared
ClearedNSite Scoliosis Assessment App
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nsite, Inc. · LDK Device, Sensing, Optical Contour
Cleared on Nov 15, 2023 as substantially equivalent to K923792 (Quantec Image Processing, Ltd., 1994) after a 267-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Nov 15, 2023
- Review
- 267 days
- Class
- Class U
- Product code
- LDK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K923792 (1994). No later device cites it as a predicate yet.
- Root · 1 generation backK923792 Quantec Spinal Measuement SystemQuantec Image Processing, Ltd. · 1994
- This deviceK230463 NSite Scoliosis Assessment AppNsite, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K923792 | Quantec Spinal Measuement System | Quantec Image Processing, Ltd. | 1994 | — |
| 0 (this device) | K230463 | NSite Scoliosis Assessment App | Nsite, Inc. | 2023 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LDK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LDK device
- #1 K232023 Momentum Spinescore 6.1 · 1 generation · no Class I recall
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K923792 | Quantec Spinal Measuement SystemSummary page 5…Unclassified, Pre-Amendment Product Code: LDK Review Panel: Physical Medicine Substantially Equivalent Device: K923792 – Quantec Image Processing Ltd. Quantec Spinal Measurement System Device Description: NSite Medical… | 1994 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 2 other devices also cite its predicate K923792.
How does its category compare?
All LDK devicesLDK Device, Sensing, Optical Contour: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · LDK
2in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · LDK
Too few LDK 510(k)s in any year since 2007 to give a median.
Recalls per year · LDK
No recall names LDK since 2007.
Adverse event reports per year · LDK
1in 2018
MAUDE reports naming product code LDK, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The NSite Scoliosis Assessment App is intended as an adjunct tool for qualified healthcare professionals to provide deformity measurements and guide management recommendations based on a calculated Asymmetry Index for patients with or at risk for idiopathic scoliosis, which will yield an output of low or high risk of clinically significant scoliosis, which is defined as a Cobb Angle greater than 20 degrees.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230463 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230463: NSite Scoliosis Assessment App.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230463
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026