INTRAVASCULAR IMAGING SYSTEM/MODIFIED
Device Facts
| Record ID | K910281 |
|---|---|
| Device Name | INTRAVASCULAR IMAGING SYSTEM/MODIFIED |
| Applicant | Intertherapy, Inc. |
| Product Code | JOP · Cardiovascular |
| Decision Date | May 13, 1991 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.2880 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An ultrasonic transducer is a device applied to the skin to transmit and receive ultrasonic energy that is used in conjunction with an echocardiograph to provide imaging of cardiovascular structures. This device includes phased arrays and two-dimensional scanning transducers.
