The following data is part of a premarket notification filed by Canon Medical Systems Corporation with the FDA for Aplio A550, Aplio A450, Aplio A, Diagnostic Ultrasound System, Software V5.1.
| Device ID | K202364 |
| 510k Number | K202364 |
| Device Name: | Aplio A550, Aplio A450, Aplio A, Diagnostic Ultrasound System, Software V5.1 |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | Canon Medical Systems Corporation 1385 Shimoishigami Otawara-shi, JP 324-8550 |
| Contact | Paul Biggins |
| Correspondent | Orlando Tadeo, Jr. Canon Medical Systems USA, Inc. 2441 Michelle Drive Tustin, CA 92780 |
| 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 | 2020-08-19 |
| Decision Date | 2020-10-15 |