The following data is part of a premarket notification filed by Canon Medical Systems Corporation with the FDA for Aplio I900/i800/i700/i600 Diagnostic Ultrasound System, V3.1.
| Device ID | K182679 |
| 510k Number | K182679 |
| Device Name: | Aplio I900/i800/i700/i600 Diagnostic Ultrasound System, V3.1 |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | Canon Medical Systems Corporation 1385 Shimoishigami Otawara-shi, JP 324-8550 |
| Contact | Paul Biggins |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| 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 | Yes |
| Combination Product | No |
| Date Received | 2018-09-26 |
| Decision Date | 2018-10-31 |
| Summary: | summary |