SenoBright HD— 510(k) K211215

Name: FDA 510(k) clearance K211215
Creator: U.S. Food and Drug Administration
Published: 2021-06-22

Substantially Equivalent

GE Healthcare

FDA 510(k) clearance K211215 for SenoBright HD, Substantially Equivalent on 2021-06-22. Applicant: GE Healthcare. Device class: 2.

Clearance details

Applicant: GE Healthcare
Product code: Code MUE
Device class: Class 2
Regulation: 21 CFR 892.1715
Advisory panel: Radiology
Date received: 2021-04-23
Decision date: 2021-06-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Buc, FR

Download summary PDF View on FDA.gov ↗

Recent devices under product code MUE

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K254090 — I-View®2026-09-02
K253678 — MAMMOMAT B.brilliant (11372950)2026-06-18
K254092 — Bellalun 2D (VDMS-1000S)2026-05-28
K260087 — Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena Bright2026-03-24
K243420 — HESTIA2025-07-17

More clearances from GE Healthcare

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K253639 — View2026-01-08
K242925 — MR Contour DL2025-04-01
K232346 — Digital Expert Access with Remote Scanning2023-10-27
K223212 — Precision DL2023-04-27
K221680 — Xeleris V Processing and Review System2023-03-01

Adverse events under product code MUE

product code MUE

Death: 5
Other: 1
Total: 6

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 K211215

K-number listed on FDA's recall record

Z-0862-2024 — Senographe PristinaClass II·Ongoing·GE Medical Systems, SCS·20231226

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K211215.

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