# K122973: AL-106, AL-106SA and AL-106B Medgyn Digital Video Colposcope

- Pathway: 510(k) (Traditional)
- Applicant: Medgyn Products, Inc.
- Decided: Jun 12, 2013 after 259 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: 2 generations back to K940094 (1995). 4 ancestors in all.
7 later devices descend from it; 5 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021153: Goldway Digital Video Colposcope Imaging System, Model #SLC-2000, Goldway Us, Inc. (2003) Summary page 1.

## Most influential descendants
- K161871: EVA (Enhanced Visual Assessment) System (2016), 1 descendant of its own
- K140754: Cooper Surgical Leisegang Colposcope System (2014), 1 descendant of its own
- K202915: IRIS Thermocoagulator and Digital Colposcope (2021), 0 descendants of its own
- K190187: Gynescope System (2019), 0 descendants of its own
- K182764: Biop Digital Colposcope (2018), 0 descendants of its own

## Indications for use
MedGyn's Digital Video Colposcope is intended for magnified viewing of the tissues of the vagina, cervix and external genitalia in order to assist doctors in diagnosing abnormalities such as lesions or cancer, and selecting areas for biopsy. The images from the Digital Video Colposcope are to be viewed on a color monitor. The Digital Video Colposcope is intended for use in hospitals, clinics, and doctor’s offices.

Source page: https://510kreport.com/device/K122973
Methodology: https://510kreport.com/methodology