510(k) K191008
K191008 is an FDA 510(k) premarket notification submitted by Boston Scientific Corporation for the device "iLab Polaris Multi-Modality Guidance System". The FDA issued a decision of Substantially Equivalent on Jul 2, 2019. The device falls under product code DQK (Computer, Diagnostic, Programmable), a Class II device regulated under 21 CFR 870.1425. Boston Scientific Corporation has 238 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 2, 2019
- Date Received
- Apr 16, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Computer, Diagnostic, Programmable
- Device Class
- Class II
- Regulation Number
- 870.1425
- Review Panel
- CV
- Submission Type
- 510(k)