ImageGrid StreamVue— 510(k) K262143
Substantially EquivalentCandelis, Inc.
FDA 510(k) clearance K262143 for ImageGrid StreamVue, Substantially Equivalent on 2026-07-23. Applicant: Candelis, Inc.. Device class: 2.
Summary
Candelis's ImageGrid StreamVue is filed under LLZ, radiological image processing systems. The record doesn't describe what the system does beyond that code name.
Class II, 21 CFR 892.2050. Radiology is both the classification panel and the review panel, and it was a Traditional 510(k).
Candelis filed from Beverly Hills, California. Review took 28 calendar days (June 25 to July 23, 2026). The record flags it as a third-party review.
Clearance details
- Applicant
- Candelis, Inc.
- Product code
- Product code LLZ
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Beverly Hills, CA, US
Recent devices under product code LLZ
view allMore clearances from Candelis, Inc.
view allAdverse events under product code LLZ
product code LLZ- Death
- 13
- Total
- 13
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.