The following data is part of a premarket notification filed by Exo Imaging Inc. with the FDA for Exo Iris (el2001).
| Device ID | K222198 |
| 510k Number | K222198 |
| Device Name: | Exo Iris (El2001) |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | Exo Imaging Inc. 4201 Burton Drive Santa Clara, CA 95054 |
| Contact | Antoanela Gomard |
| Correspondent | Antoanela Gomard Exo Imaging Inc. 4201 Burton Drive Santa Clara, CA 95054 |
| 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 | 2022-07-22 |
| Decision Date | 2022-11-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850018318006 | K222198 | 000 |
| 00850018318068 | K222198 | 000 |