# K182764: Biop Digital Colposcope

- Pathway: 510(k) (Traditional)
- Applicant: Biop Medical, Ltd.
- Decided: Nov 27, 2018 after 60 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: 3 generations back to K940094 (1995). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122973: AL-106, AL-106SA and AL-106B Medgyn Digital Video Colposcope, Medgyn Products, Inc. (2013) Summary page 4.

## Indications for use
The Biop Digital 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 Colposcope are to be viewed on a color display. The Biop Digital Colposcope is intended for use in hospitals, clinics, and doctor's offices.

Source page: https://510kreport.com/device/K182764
Methodology: https://510kreport.com/methodology