510(k) K201178
K201178 is an FDA 510(k) premarket notification submitted by Boston Scientific for the device "iLab Polaris Multi-Modality Guidance System". The FDA issued a decision of Substantially Equivalent on May 29, 2020. The device falls under product code DQK (Computer, Diagnostic, Programmable), a Class II device regulated under 21 CFR 870.1425. Boston Scientific has 493 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 29, 2020
- Date Received
- May 1, 2020
- Clearance Type
- Special
- 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)