K123535 is an FDA 510(k) clearance for the ILAB ULTRASOUND IMAGING SYSTEM. This device is classified as a System, Imaging, Pulsed Echo, Ultrasonic (Class II - Special Controls, product code IYO).
Submitted by Boston Scientific Corp (Fremont, US). The FDA issued a Cleared decision on January 15, 2013, 60 days after receiving the submission on November 16, 2012.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1560.
| 510(k) Number | K123535 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 16, 2012 |
| Decision Date | January 15, 2013 |
| Days to Decision | 60 days |
| Submission Type | Special |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | IYO — System, Imaging, Pulsed Echo, Ultrasonic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1560 |