Ambra ProViewer— 510(k) K202335

Name: FDA 510(k) clearance K202335
Creator: U.S. Food and Drug Administration
Published: 2020-09-04

Substantially Equivalent

Dicom Grid Inc Dba Ambra Health

FDA 510(k) clearance K202335 for Ambra ProViewer, Substantially Equivalent on 2020-09-04. Applicant: Dicom Grid Inc Dba Ambra Health. Device class: 2.

Clearance details

Applicant: Dicom Grid Inc Dba Ambra Health
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2020-08-17
Decision date: 2020-09-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LLZ

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Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K202335

K-number listed on FDA's recall record

Z-1818-2022 — Ambra PACS, Ambra ProViewer. Software for use as a primary diagnostic and analysis tool for diagnostic images.Class II·Ongoing·DICOM Grid, Inc. d/b/a Ambra Health·20220623

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K202335.

Data sourced from openFDA. This site is unofficial and independent of the FDA.