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, V4.0.
| Device ID | K191467 |
| 510k Number | K191467 |
| Device Name: | Aplio I900/i800/i700/i600 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 | 2019-06-03 |
| Decision Date | 2019-07-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04987670103742 | K191467 | 000 |
| 04987670103063 | K191467 | 000 |
| 04987670103070 | K191467 | 000 |
| 04987670103087 | K191467 | 000 |
| 04987670103094 | K191467 | 000 |
| 04987670103100 | K191467 | 000 |
| 04987670103117 | K191467 | 000 |
| 04987670103124 | K191467 | 000 |
| 04987670103537 | K191467 | 000 |
| 04987670103544 | K191467 | 000 |
| 04987670103551 | K191467 | 000 |
| 04987670103568 | K191467 | 000 |
| 04987670103735 | K191467 | 000 |
| 04987670102547 | K191467 | 000 |