Senographe Pristina— 510(k) K162268
Substantially EquivalentGE Healthcare
FDA 510(k) clearance K162268 for Senographe Pristina, Substantially Equivalent on 2016-11-03. 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
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Buc, FR
Recent devices under product code MUE
view allMore clearances from GE Healthcare
view allAdverse events under product code MUE
product code MUE- Death
- 5
- Other
- 1
- Total
- 6
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 →
Recalls naming K162268
K-number listed on FDA's recall record- Z-0875-2026 — Senographe Pristina, Pristina Serena, and Pristina Serena 3D. for screening and diagnostic mammography
- Z-0862-2024 — Senographe Pristina
- Z-2131-2019 — GE Senographe Pristina - Product Usage: Senographe Pristina generates digital mammographic images that can be used for screening and in the diagnosis of breast cancer. Senographe Pristina is intended to be used in the same clinical applications as traditional film-based mammographic systems.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K162268.
Data sourced from openFDA. This site is unofficial and independent of the FDA.