The following data is part of a premarket notification filed by Canon Medical Systems Corporation with the FDA for Aplio A550 And A450, Software V2.8 Diagnostic Ultrasound System.
| Device ID | K182427 |
| 510k Number | K182427 |
| Device Name: | Aplio A550 And A450, Software V2.8 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 Jr Canon Medical Systems Corporation 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 | 2018-09-06 |
| Decision Date | 2018-11-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04987670103353 | K182427 | 000 |
| 04987670103346 | K182427 | 000 |