The following data is part of a premarket notification filed by Pie Medical with the FDA for Mylab15/20 3d/4d Ultrasound Imaging System.
| Device ID | K053154 |
| 510k Number | K053154 |
| Device Name: | MYLAB15/20 3D/4D ULTRASOUND IMAGING SYSTEM |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | PIE MEDICAL 7992 CASTLEWAY DRIVE Indianapolis, IN 46250 |
| Contact | Carri Graham |
| Correspondent | Carri Graham PIE MEDICAL 7992 CASTLEWAY DRIVE Indianapolis, IN 46250 |
| Product Code | IYN |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-11-14 |
| Decision Date | 2005-12-16 |
| Summary: | summary |