510(k) · Cleared
ClearedCryoVizion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cryos Technologies, Inc. · LDK Device, Sensing, Optical Contour
Cleared on Aug 28, 2019 as substantially equivalent to K923792 (Quantec Image Processing, Ltd., 1994) after a 254-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Aug 28, 2019
- Review
- 254 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 deviceK183485 CryoVizion SystemCryos Technologies, Inc. · 2019
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) | K183485 | CryoVizion System | Cryos Technologies, Inc. | 2019 | — |
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 K230463 NSite Scoliosis Assessment Appscore 6.4 · 1 generation · no Class I recall
- #2 Held for the reportin the report
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 4…al Medicine Product Code LDK 6. Identification of the Predicate Predicate Device Name: Quantec Spinal Measurement System 510(k) Number: K923792 7. Intended Use and Indication for Use The CryoVizion is indicated as a tool to quantify angles on digital photograph depic… | 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. 2019, 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 CryoVizion is indicated as a tool to quantify angles on digital photograph depictions such as body angles related to postural asymmetries. It is intended for use in professional health care facilities by health specialists such as podiatrists, orthopedist, physiotherapists, chiropractors, osteopaths, and kinesiotherapists
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183485 · printed Nov 4, 2026
Cite this page
510(k) Report. “K183485: CryoVizion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K183485
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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