The following data is part of a premarket notification filed by Intuitive Surgical with the FDA for Iris 1.0 System.
| Device ID | K182643 |
| 510k Number | K182643 |
| Device Name: | IRIS 1.0 System |
| Classification | System, Image Processing, Radiological |
| Applicant | Intuitive Surgical 1266 Kifer Road Sunnyvale, CA 94086 |
| Contact | Crystal Ong |
| Correspondent | Crystal Ong Intuitive Surgical 1266 Kifer Road Sunnyvale, CA 94086 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-24 |
| Decision Date | 2019-02-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00886874117538 | K182643 | 000 |
| 00886874117507 | K182643 | 000 |