RadioViewAI— 510(k) K260936

Substantially Equivalent

Neurocareai, Inc. (Dba Savelife.Ai)

FDA 510(k) clearance K260936 for RadioViewAI, Substantially Equivalent on 2026-07-31. Applicant: Neurocareai, Inc. (Dba Savelife.Ai). Device class: 2.

Summary

RadioViewAI from Neurocareai (doing business as Savelife.Ai) 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. It came in as a Traditional 510(k).

Neurocareai filed from Prosper, Texas. Review took 133 calendar days (March 20 to July 31, 2026).

Clearance details

Applicant
Neurocareai, Inc. (Dba Savelife.Ai)
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
Prosper, TX, US
Download summary PDFView on FDA.gov ↗

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Adverse 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.