DC-1 Cardiac Imaging Module
by Diasonics, Inc. 510(k)
Active
510(k) K811556
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK811556 | Date10 Jul 1981 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- DXK
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.2330
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 21 Sep 2026
The DC-1 Cardiac Imaging Module is an echocardiograph device used for cardiovascular imaging. It is classified as a Class II medical device under regulation number 870.2330.
The device received FDA 510(k) clearance (K811556) on July 10, 1981, and is manufactured by Diasonics, Inc. It is supplied as a non-sterile, reusable module intended for use in clinical cardiovascular imaging settings.
Other devices from Diasonics, Inc.
Questions
AI-generated answers, 21 Sep 2026
What is the DC-1 Cardiac Imaging Module used for?
The DC-1 Cardiac Imaging Module is an echocardiograph device used for cardiovascular imaging in clinical settings, as specified in its FDA 510(k) clearance documentation.
Is the DC-1 Cardiac Imaging Module sterile or non-sterile, and is it single-use or reusable?
The device is supplied as a non-sterile, reusable module, meaning it is not provided in a sterile condition and is intended for multiple uses after appropriate cleaning and reprocessing in clinical cardiovascular imaging environments.
What regulatory pathway was used for the DC-1 Cardiac Imaging Module, and when was it cleared?
The DC-1 Cardiac Imaging Module received FDA 510(k) clearance under the traditional pathway, with clearance granted on July 10, 1981, under K811556, indicating it was found substantially equivalent to a predicate device.