The following data is part of a premarket notification filed by Canon Medical Systems Corporation with the FDA for Aplio I900/i800/i700 Diagnostic Ultrasound System, Software V6.5.
| Device ID | K212333 |
| 510k Number | K212333 |
| Device Name: | Aplio I900/i800/i700 Diagnostic Ultrasound System, Software V6.5 |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | Canon Medical Systems Corporation 1385 Shimoishigami Otawara-shi, JP 324-8550 |
| Contact | Paul Biggins |
| Correspondent | Yoshiaki Cook 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 | 2021-07-27 |
| Decision Date | 2022-01-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04987670104176 | K212333 | 000 |