# K233043: Smart Scope® CX

- Pathway: 510(k) (Traditional)
- Applicant: Periwinkle Technologies Pvt., Ltd.
- Decided: Jun 14, 2024 after 263 days
- Product code: HEX (Colposcope (And Colpomicroscope))
- Device class: 2
- Regulation: 21 CFR 884.1630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K940094 (1995). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181034: Pocket Colposcope System, Hadleigh Health Technologies, LLC (2018) Summary page 6.

## Indications for use
Smart Scope® CX is intended for gynecological examination. It provides a portable means of magnified visualization of the tissues of the vagina, cervix, and external genitalia to aid in diagnosing abnormalities and selecting areas for biopsy. The Net4Medix® application is intended to provide documentation of the image in the field of view of the scope. The Smart Scope® CX camera probe is intended to be inserted into the vagina via a speculum by trained medical personnel in hospitals, clinics, and private offices, and is not intended for home use.

Source page: https://510kreport.com/device/K233043
Methodology: https://510kreport.com/methodology