The following data is part of a premarket notification filed by Boston Scientific Corp. with the FDA for Ilab Ultrasound Imaging System, Version 1.3.
| Device ID | K072517 |
| 510k Number | K072517 |
| Device Name: | ILAB ULTRASOUND IMAGING SYSTEM, VERSION 1.3 |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | BOSTON SCIENTIFIC CORP. 47900 BAYSIDE PARKWAY Fremont, CA 94538 -6515 |
| Contact | Christine Dunbar |
| Correspondent | Christine Dunbar BOSTON SCIENTIFIC CORP. 47900 BAYSIDE PARKWAY Fremont, CA 94538 -6515 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-09-07 |
| Decision Date | 2007-09-26 |
| Summary: | summary |