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, Aplio A550, Aplio A450, And Aplio A, Diagnostic Ultrasound System, Xario200g And Xario100g, Diagnostic Ultrasound System.
| Device ID | K202737 |
| 510k Number | K202737 |
| Device Name: | Aplio I900/i800/i700/i600 Diagnostic Ultrasound System, Aplio A550, Aplio A450, And Aplio A, Diagnostic Ultrasound System, Xario200G And Xario100G, Diagnostic Ultrasound System |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | Canon Medical Systems Corporation 1385 Shimoishigami Otawara-shi, JP 324-8550 |
| Contact | Paul Biggins |
| Correspondent | Orlando Tadeo 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-18 |
| Decision Date | 2020-10-16 |