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 | K151613 |
510k Number | K151613 |
Device Name: | ILab Polaris Multi-Modality Guidance System |
Classification | Computer, Diagnostic, Programmable |
Applicant | BOSTON SCIENTIFIC CORPORATION ONE SCIMED PLACE Maple Grove, MN 55311 |
Contact | Arlene Roche |
Correspondent | Arlene Roche BOSTON SCIENTIFIC CORPORATION ONE SCIMED PLACE Maple Grove, MN 55311 |
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 | 2015-06-15 |
Decision Date | 2015-10-06 |
Summary: | summary |