510(k) Report

510(k) · Cleared

Cleared

Quantec Spinal Measuement System

K923792510(k) TraditionalCleared Apr 20, 1994631-day reviewClass U

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Quantec Image Processing, Ltd. · LDK Device, Sensing, Optical Contour

Cleared on Apr 20, 1994 after a 631-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 3 later devices descend from it.

Decided
Apr 20, 1994
Review
631 days
Class
Class U
Product code
LDK
Recalls
None
Predicates
0

3 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2019: 1 descendant cleared2023: 2 descendants cleared1990200020102020
  1. This deviceK923792 Quantec Spinal Measuement SystemQuantec Image Processing, Ltd. · 1994
  2. Descendant · cites it directly · 0 of its ownK230463 NSite Scoliosis Assessment AppNsite, Inc. · 2023
  3. Descendant · cites it directly · 0 of its ownK232023 Momentum SpineMomentum Health, Inc. · 2023
  4. Descendant · cites it directly · 0 of its ownK183485 CryoVizion SystemCryos Technologies, Inc. · 2019

Most influential descendants

Showing 3 of 3 · See all
  • K230463NSite Scoliosis Assessment AppNsite, Inc. · 2023 · cites it directly0descendants
  • K232023Momentum SpineMomentum Health, Inc. · 2023 · cites it directly0descendants
  • K183485CryoVizion SystemCryos Technologies, Inc. · 2019 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K923792Quantec Spinal Measuement SystemQuantec Image Processing, Ltd.1994—
+1K230463NSite Scoliosis Assessment AppNsite, Inc.2023—
+1K232023Momentum SpineMomentum Health, Inc.2023—
+1K183485CryoVizion SystemCryos Technologies, Inc.2019—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201910
202320
FIG. 1 — Lineage of K923792, 1994–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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. #1 K230463 NSite Scoliosis Assessment Appscore 6.4 · 1 generation · no Class I recall
  2. #2 Held for the reportin the report
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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (3)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K230463NSite Scoliosis Assessment AppNsite, Inc.20230
K232023Momentum SpineMomentum Health, Inc.20230
K183485CryoVizion SystemCryos Technologies, Inc.20190

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?

  • Of its descendants, K230463 (Nsite, Inc., 2023) has gone furthest, with 0 descendants of its own.

How does its category compare?

All LDK devices

LDK Device, Sensing, Optical Contour: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LDK

2in 2023

2019: 12023: 2
2007high 2 (2023) · low 0 (2007)2026

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

2018: 1
2007high 1 (2018) · low 0 (2007)2025

MAUDE reports naming product code LDK, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—01
20191—00
20200—00
20210—00
20220—00
20232—00
20240—00
20250—00
20260—0—

Recent decisions in LDK

The LDK category page

  • K230463NSite Scoliosis Assessment AppNsite, Inc. · 2023
  • K232023Momentum SpineMomentum Health, Inc. · 2023
  • K183485CryoVizion SystemCryos Technologies, Inc. · 2019
  • K860225MetricomFar Orthopedics, Inc. · 1986
  • K851133Terran Biomechanical Analysis SystemTerran Biomedical Instruments · 1985

https://510kreport.com/device/K923792 · printed Nov 4, 2026

Cite this page

510(k) Report. “K923792: Quantec Spinal Measuement System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K923792

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026