Chrysalis Intelligence · Sponsors · GE Medical Systems SCS

GE Medical Systems SCS

Buc, FR · 23 510(k) clearances · 9 recalls

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Total clearances
23
2020-01-24 → 2026-07-21
Last 12 months
3
Product codes
5
Most recent
2026-07-21
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
JAK System, X-Ray, Tomography, Computed Class II Radiology 9 2026-07-21
LLZ System, Image Processing, Radiological Class II Radiology 7 2025-04-21
OWB — — — 3 2025-12-09
KPS System, Tomography, Computed, Emission Class II Radiology 3 2022-11-22
MUE Full Field Digital, System, X-Ray, Mammographic Class II Radiology 1 2026-03-24
Safety

Recalls (9)

Class I (serious)
0
Risk of injury / death
Total recalls
9
Currently ongoing
9
Most recent
2025-09-05
DateSeverityStatusRecall # ProductCodeReason
2025-09-05 Class II Ongoing Z-0068-2026 AW Server 2.0, AW Server 3.0, AW Server 3.1, AW Server 3.2 — Firm has identified a security vulnerability in AW Server products. If exploited, a malicious actor could compromise the confidentiality, integrity, and availab…
2024-03-18 Class II Ongoing Z-1783-2024 GE Healthcare Allia IGS 5 Pulse, Interventional fluoroscopic x-ray systems — GE HealthCare has become aware of the potential that adhesive material might not have been applied to some bolts of certain Innova IGS, Discovery IGS, Interact …
2024-03-18 Class II Ongoing Z-1782-2024 GE Healthcare Allia IGS 5 Pulse, Interventional fluoroscopic x-ray systems — GE HealthCare has become aware of the potential that adhesive material might not have been applied to some bolts of certain Innova IGS, Discovery IGS, Interact …
2024-03-18 Class II Ongoing Z-1781-2024 GE Healthcare Allia IGS 7 OR, Interventional fluoroscopic x-ray systems — GE HealthCare has become aware of the potential that adhesive material might not have been applied to some bolts of certain Innova IGS, Discovery IGS, Interact …
2024-03-18 Class II Ongoing Z-1780-2024 GE Healthcare Allia IGS 7, Interventional fluoroscopic x-ray systems — GE HealthCare has become aware of the potential that adhesive material might not have been applied to some bolts of certain Innova IGS, Discovery IGS, Interact …
2024-03-18 Class II Ongoing Z-1779-2024 GE Healthcare Interact Discovery RT, Interventional fluoroscopic x-ray systems — GE HealthCare has become aware of the potential that adhesive material might not have been applied to some bolts of certain Innova IGS, Discovery IGS, Interact …
2024-03-18 Class II Ongoing Z-1778-2024 GE Healthcare Innova IGS 6, Interventional fluoroscopic x-ray systems — GE HealthCare has become aware of the potential that adhesive material might not have been applied to some bolts of certain Innova IGS, Discovery IGS, Interact …
2024-03-18 Class II Ongoing Z-1777-2024 GE Healthcare Innova IGS 5, computed tomography x-ray system — GE HealthCare has become aware of the potential that adhesive material might not have been applied to some bolts of certain Innova IGS, Discovery IGS, Interact …
2023-12-26 Class II Ongoing Z-0862-2024 Senographe Pristina — X-ray exposure termination audible signal on Senographe Pristina with Efficiency Suite 2 intermittently not emitted per 21CFR 1020.31(j) requirements.
Filings

All 510(k) clearances (23)

Date K-number Device Code Class Specialty
2026-07-21 K253770 CardIQ Suite JAK Class II Radiology
2026-03-24 K260087 Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena Bright MUE Class II Radiology
2025-12-09 K251199 Allia Moveo OWB — —
2025-06-18 K243672 CardIQ Suite JAK Class II Radiology
2025-04-21 K243651 VersaViewer LLZ Class II Radiology
2025-02-25 K243446 3DXR OWB — —
2024-08-01 K233731 CardIQ Suite JAK Class II Radiology
2024-01-25 K233714 BreView LLZ Class II Radiology
2023-10-11 K232344 Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 OR OWB — —
2023-07-13 K223424 Spine Auto Views JAK Class II Radiology
2023-03-21 K223490 FlightPlan for Embolization LLZ Class II Radiology
2022-11-22 K223152 Vision 2, EVARVision, TrackVision 2, HeartVision 2 LLZ Class II Radiology
2022-11-22 K222895 DynamicIQ KPS Class II Radiology
2022-05-02 K211180 Liver Suite JAK Class II Radiology
2022-03-11 K213725 CardIQ Suite JAK Class II Radiology
2021-10-22 K210807 FlightPlan for Liver LLZ Class II Radiology
2021-07-27 K211247 PET VCAR KPS Class II Radiology
2021-02-16 K200626 VesselIQ Xpress JAK Class II Radiology
2020-11-17 K193306 PROView LLZ Class II Radiology
2020-11-12 K193289 FastStroke, CT Perfusion 4D JAK Class II Radiology
2020-03-20 K193281 Hepatic VCAR JAK Class II Radiology
2020-02-14 K192277 CardIQ Flow KPS Class II Radiology
2020-01-24 K193261 FlightPlan for Embolization LLZ Class II Radiology
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence