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Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena Bright

by GE Medical Systems SCS

510(k) K260087

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K260087↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK260087 Date24 Mar 2026ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
MUE
Models / Variants
Device Class
Class II
Regulation
21 CFR Part 892.1715
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Senographe Pristina; SenoBright HD; Pristina Serena; and Pristina Serena Bright are full-field digital mammographic X-ray systems designed for breast imaging. These devices provide high-resolution, low-dose imaging to support screening and diagnostic mammography, including contrast-enhanced applications.

These systems are intended for use in radiology departments and are supplied as reusable medical equipment. They are classified as Class II devices under FDA regulations and have received FDA 510(k) clearance and MDR authorisation. The devices require proper installation, calibration, and maintenance in accordance with manufacturer guidelines to ensure accurate imaging and patient safety.

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