The following data is part of a premarket notification filed by Optimal Imaging Systems, Inc. with the FDA for Ois-stand Alone Diagnostic Ultrasound System.
| Device ID | K000034 |
| 510k Number | K000034 |
| Device Name: | OIS-STAND ALONE DIAGNOSTIC ULTRASOUND SYSTEM |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | OPTIMAL IMAGING SYSTEMS, INC. 9344 NW 13TH ST. SUITE 200 Miami, FL 33172 |
| Contact | Jorge Millian |
| Correspondent | Jorge Millian OPTIMAL IMAGING SYSTEMS, INC. 9344 NW 13TH ST. SUITE 200 Miami, FL 33172 |
| Product Code | IYN |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-01-06 |
| Decision Date | 2000-02-24 |