Pristina Serena— 510(k) K173576
Substantially EquivalentGE Healthcare
FDA 510(k) clearance K173576 for Pristina Serena, Substantially Equivalent on 2018-05-14. 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 K173576
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-2132-2019 — GE Pristina Serena - Product Usage: Pristina Serena is an optional accessory of Senographe Pristina intended to provide accurate location of lesions in the breast in three dimensions.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K173576.
Data sourced from openFDA. This site is unofficial and independent of the FDA.