# K100531: Viscope, Model 100P,100S

- Pathway: 510(k) (Traditional)
- Applicant: Hd Medical Services (India) Pvt.Ltd
- Decided: Jul 21, 2010 after 147 days
- Product code: DQD (Stethoscope, Electronic)
- Device class: 2
- Regulation: 21 CFR 870.1875
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K771653 (1977). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990809: Cadiscope Electronic Stethoscope, Caditec AG (1999) Summary page 2.
- K083903: 3M Littmann Electronic Stethoscope, Model 3200, 3M Company (2009) Summary page 2.
- K090493: Signal, Zargis Medical Corp. (2009) Summary page 2.

## Indications for use
The ViScope Electronic Stethoscope is a patented electronic stethoscope with an integrated graphics display to show amplified heart sounds as phonocardiograms. It is intended for use as a diagnostic aid as part of a physical assessment of a patient by health care professionals or other individuals trained to administer emergency first aid or otherwise care for a patient. It can be used for the amplification of heart, lung, blood vessel, enteral and other body sounds.

Source page: https://510kreport.com/device/K100531
Methodology: https://510kreport.com/methodology