iLab Polaris Multi-Modality Guidance System
FDA 510(k) K151613 · Boston Scientific Corporation
510(k) numberK151613
Submission
- Device name
- iLab Polaris Multi-Modality Guidance System
- Applicant
- Boston Scientific Corporation
Maple Grove, MN, US - Received
- June 15, 2015
- Decision date
- October 6, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQK – Computer, Diagnostic, Programmable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1425
- Specialty
- Cardiovascular
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Questions and answers
When was iLab Polaris Multi-Modality Guidance System cleared by the FDA?
iLab Polaris Multi-Modality Guidance System (K151613) received a 510(k) decision of Substantially Equivalent on October 6, 2015, 113 days after the submission was received.
What is the product code of K151613?
The FDA product code is DQK – Computer, Diagnostic, Programmable, a Class II (moderate risk) device regulated under 21 CFR 870.1425.