510(k) · Cleared
ClearedCM 3910 Rotating Double Scheimpflug Camera
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sis Ltd., Surgical Instrument Systems · MXK Device, Analysis, Anterior Segment
Cleared on Sep 28, 2005 after a 72-day review. The FDA summary names its predicate without a number. 3 later devices descend from it.
- Decided
- Sep 28, 2005
- Review
- 72 days
- Class
- Class II
- Product code
- MXK
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK051940 CM 3910 Rotating Double Scheimpflug CameraSis Ltd., Surgical Instrument Systems · 2005
- Descendant · cites it directly · 1 of its ownK162067 VX130 Ophthalmic Diagnostic DeviceLuneau Sas · 2017
- Descendant · 2 generations on · 0 of its ownK202221 VX650Luneau Technology Operations · 2021
- Descendant · cites it directly · 0 of its ownK182659 Galilei G6 Lens ProfessionalSis Ag, Surgical Instrument Systems · 2019
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K051940 | CM 3910 Rotating Double Scheimpflug Camera | Sis Ltd., Surgical Instrument Systems | 2005 | — |
| +1 | K162067 | VX130 Ophthalmic Diagnostic Device | Luneau Sas | 2017 | — |
| +2 | K202221 | VX650 | Luneau Technology Operations | 2021 | — |
| +1 | K182659 | Galilei G6 Lens Professional | Sis Ag, Surgical Instrument Systems | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
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 MXK? 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 MXK device
- #1 K251848 Pentacam® Cornea OCTscore 13.7 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | — | Pentacam Scheimpflug Camera of OCULUS Optikgeräte GmbH Named without a submission number | |
| * | — | Orbscan II Keratometer manufactured by Orbtek, Inc. Named without a submission number |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K162067 (Luneau Sas, 2017) has gone furthest, with 1 descendant of its own.
How does its category compare?
All MXK devicesMXK Device, Analysis, Anterior Segment: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MXK
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MXK
Too few MXK 510(k)s in any year since 2007 to give a median.
Recalls per year · MXK
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MXK
1in 2025
MAUDE reports naming product code MXK, 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 | 1 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 1 | 2 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 2 | — | 0 | 2 |
| 2020 | 1 | — | 0 | 2 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 1 | — | 0 | 1 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The CM3910 is a device intended to take images of the anterior segment of the eye which includes the cornea, iris, pupil, anterior chamber and lens, to evaluate and analyse
* Corneal shape
* Lens shape
* Pachymetry (thickness of the cornea)
* Pupil size
* Lens thickness
* Condition of the lens
o Location of cataracts (nuclear, subcapsular and or cortical), using Scheimpflug slit imaging with densitometry
o State of the lens (opaque crystalline lens)
* Condition and position of implants (e.g. IOLs, phakik IOLs, intracorneal rings)
* Anterior chamber (size, volume and angle)
* Scheimpflug Image
* Position of the cornea relative to iris and lens
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051940 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051940: CM 3910 Rotating Double Scheimpflug Camera.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051940
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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