# K031436: Mediscope

- Pathway: 510(k) (Traditional)
- Applicant: Sometech Corporation
- Decided: Dec 19, 2003 after 227 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: 1 generation back to K955635 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955635: Video Colposcope/Vertical Rolling Base/Swing Arm Stand, Welch Allyn, Inc. (1996) Summary page 2.

## Indications for use
MEDISCOPE, colposcope (Obstetrical and Gynecological Diagnostic Device), is intended for magnified viewing of the tissues of cervix.

Source page: https://510kreport.com/device/K031436
Methodology: https://510kreport.com/methodology