The following data is part of a premarket notification filed by Canon Medical Systems Corporation with the FDA for Aplio A550, Aplio A450 And Aplio A, Diagnostic Ultrasound System, V4.0.
| Device ID | K191663 |
| 510k Number | K191663 |
| Device Name: | Aplio A550, Aplio A450 And Aplio A, Diagnostic Ultrasound System, V4.0 |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-21 |
| Decision Date | 2019-09-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04987670103780 | K191663 | 000 |