AdvaView— 510(k) K262449
Substantially EquivalentADVAHEALTH SOLUTIONS, LLC
FDA 510(k) clearance K262449 for AdvaView, Substantially Equivalent on 2026-08-14. Applicant: ADVAHEALTH SOLUTIONS, LLC. Device class: 2.
Summary
AdvaHealth Solutions' AdvaView is filed under product code LLZ, radiological image processing systems. The record has no description beyond the name and that code.
Class II, 21 CFR 892.2050. Radiology is both the classification panel and the review panel, and it came in as a Special 510(k).
The applicant filed from Dover, Delaware. The decision came 29 calendar days after receipt (July 16 to August 14, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- ADVAHEALTH SOLUTIONS, LLC
- 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
- Special
- Location
- Dover, DE, US
Recent devices under product code LLZ
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.