The following data is part of a premarket notification filed by Boston Scientific with the FDA for Ilab Ultrasound Imaging System.
| Device ID | K152316 |
| 510k Number | K152316 |
| Device Name: | ILab Ultrasound Imaging System |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | BOSTON SCIENTIFIC 47215 Lakeview Blvd. Fremont, CA 94538 |
| Contact | George J Prendergast |
| Correspondent | George J Prendergast BOSTON SCIENTIFIC 47215 Lakeview Blvd. Fremont, CA 94538 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-17 |
| Decision Date | 2015-09-18 |
| Summary: | summary |