# K051940: CM 3910 Rotating Double Scheimpflug Camera

- Pathway: 510(k) (Traditional)
- Applicant: Sis Ltd., Surgical Instrument Systems
- Decided: Sep 28, 2005 after 72 days
- Product code: MXK (Device, Analysis, Anterior Segment)
- Device class: 2
- Regulation: 21 CFR 886.1850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Pentacam Scheimpflug Camera of OCULUS Optikgeräte GmbH: named in the summary without a submission number
- (no number) Orbscan II Keratometer manufactured by Orbtek, Inc.: named in the summary without a submission number

## Most influential descendants
- K162067: VX130 Ophthalmic Diagnostic Device (2017), 1 descendant of its own
- K202221: VX650 (2021), 0 descendants of its own
- K182659: Galilei G6 Lens Professional (2019), 0 descendants of its own

## Indications for use
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

Source page: https://510kreport.com/device/K051940
Methodology: https://510kreport.com/methodology