The following data is part of a premarket notification filed by Intertherapy, Inc. with the FDA for Intravascular Imaging System/modified.
| Device ID | K910281 |
| 510k Number | K910281 |
| Device Name: | INTRAVASCULAR IMAGING SYSTEM/MODIFIED |
| Classification | Transducer, Ultrasonic |
| Applicant | INTERTHERAPY, INC. 1936 E. DEERE AVE., STE. 120 Santa Ana, CA 92705 |
| Contact | Thomas P Schroeder |
| Correspondent | Thomas P Schroeder INTERTHERAPY, INC. 1936 E. DEERE AVE., STE. 120 Santa Ana, CA 92705 |
| Product Code | JOP |
| CFR Regulation Number | 870.2880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-23 |
| Decision Date | 1991-05-13 |