DXR · Ballistocardiograph
Cardiovascular · 21 CFR 870.2320 · Class 2
Overview
| Product Code | DXR |
|---|---|
| Device Name | Ballistocardiograph |
| Regulation | 21 CFR 870.2320 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| 3rd-Party Reviewable | Yes |
Identification
A ballistocardiograph is a device, including a supporting structure on which the patient is placed, that moves in response to blood ejection from the heart. The device often provides a visual display.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (5 of 5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K243566 | CardioTag | Cardiosense, Inc. | Jul 22, 2025 | SESE |
| K160656 | CorSens | Corsens Medical , Ltd. | Nov 21, 2016 | SESE |
| K081603 | DIGITAL BALLISTOCARDIOGRAPH, MODEL DGB 300 | Heartforce Medical, Inc. | Jul 24, 2009 | SESE |
| K870442 | QUANTASCOPE | Vital Science Corp. | Aug 11, 1987 | SN |
| K863508 | FRANTZ MEDICAL ELECTRODE | Frantz Medical Development, Ltd. | Feb 6, 1987 | SESE |
Top Applicants
- Cardiosense, Inc. — 1 clearance
- Corsens Medical , Ltd. — 1 clearance
- Frantz Medical Development, Ltd. — 1 clearance
- Heartforce Medical, Inc. — 1 clearance
- Vital Science Corp. — 1 clearance
