The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Ilab Polaris Multi-modality Guidance System.
| Device ID | K191008 |
| 510k Number | K191008 |
| Device Name: | ILab Polaris Multi-Modality Guidance System |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | Boston Scientific Corporation 150 Baytech Drive San Jose, CA 95134 |
| Contact | Mugdha Dongre |
| Correspondent | Mugdha Dongre Boston Scientific Corporation 150 Baytech Drive San Jose, CA 95134 |
| Product Code | DQK |
| Subsequent Product Code | DSK |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-16 |
| Decision Date | 2019-07-02 |