# K103499: A Scope

- Pathway: 510(k) (Traditional)
- Applicant: Active Signal Technologies, Inc.
- Decided: Mar 31, 2011 after 122 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: 1 generation back to K910462 (1991). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973336: Imex Stethodop, Imex Medical Systems, Inc. (1998) Summary page 2.
- K910462: Pocket Dop 3, Imex Medical Systems, Inc. (1991) Summary page 2.
- K961301: E-Scope Electronic Stethoscope Model 718-7120, Delphi Consulting Group (1996) Summary page 2.

## Indications for use
The Active Signal A SCOPE (or noise-immune stethoscope) is intended for medical diagnostic purposes only. It may be used for the detection and amplification of acoustic signals generated by physiologic activity in the body. In the presence of relatively mild ambient noise it is used in Acoustic Mode and functions as a passive electronic stethoscope to receive sounds produced by the heart, lungs, bowel and other internal organs. To retain audibility at higher sound levels it is switched to Doppler Mode where an audible tone is produced by the ultrasound frequency-shift caused by motion of the heart and lungs. It can be used on any person undergoing a physical assessment. It is not intended to be used for diagnosis and treatment by unlicensed, untrained, or unqualified medical persons.

Source page: https://510kreport.com/device/K103499
Methodology: https://510kreport.com/methodology