Device type
System, Image Processing, Radiological
Product code LLZ · Class II · 21 CFR 892.2050 · Radiology
Recent 510(k)s
Oct 29, 2026
K263648
Vitrea Advanced Visualization, Version 7.16
Canon Medical Informatics, Inc.
- LLZ
- Class II
Oct 26, 2026
K261763
MIM – KineticID
Mim Software, Inc.
- LLZ
- Class II
Oct 21, 2026
K261788
Eden PACS
Higia., Inc. d/b/a Eden
- LLZ
- Class II
Oct 21, 2026
K261531
PV-iCurve Pro
Perception Vision Medical Technology Co., Ltd.
- LLZ
- Class II
Sep 29, 2026
K263048
Syngo Carbon Space (VA4)
Siemens Healthineers AG
- LLZ
- Class II
Sep 23, 2026
K261874
Syneris PACS v.1.0.1.0
Syneris
- LLZ
- Class II
Sep 22, 2026
K262442
HipStudio Analysis
Replasia BV
- LLZ
- Class II
Sep 18, 2026
K261855
Elucid PlaqueIQ
Elucid Bioimaging, Inc.
- LLZ
- Class II
Sep 15, 2026
K261861
SPINEsim v1.0
Mdsim S.A.
- LLZ
- Class II
Sep 15, 2026
K254214
OOOPDS
Taiwan Main Orthopaedic Biotechnology Co., Ltd.
- LLZ
- Class II
Sep 4, 2026
K262060
3D-RD-S
Radiopharmaceutical Imaging & Dosimetry, LLC
- LLZ
- Class II
Aug 17, 2026
K261500
KBA3D (v2.4.0)
S.M.A.I.O
- LLZ
- Class II
Recent recalls
Nov 4, 2026
Z-0357-2027
intelerad IntelePACS software
INTELERAD MEDICAL SYSTEMS INCORPORATED
- LLZ
- Class II
- Open, Classified
Oct 21, 2026
Z-0186-2027
IntelePACS, InteleConnect Portal/Tech Portal Versions PACS-5-1-1-R102, PACS-5-2-1-R93, PACS-5-3-1-R83 through R128, PACS-5-4-1-R66 through R101, PACS-5-5-1-R50…
INTELERAD MEDICAL SYSTEMS INCORPORATED
- LLZ
- Class II
- Ongoing
Sep 23, 2026
Z-3167-2026
Enterprise Archive V8, software product for receiving, archiving, and sending electronic medical data, All versions
GE Healthcare
- LLZ
- Class II
- Ongoing
Sep 23, 2026
Z-3168-2026
Centricity PACS V2, V3, V4, V6, V7, software product is intended for the storage, reading, diagnostic review, analysis, annotation, distribution, printing, edi…
GE Healthcare
- LLZ
- Class II
- Ongoing
Sep 23, 2026
Z-3170-2026
Workflow Core Services V8, intended to provide set of services for storage and retrieval of patient data, exams and performs system Administration, common conf…
GE Healthcare
- LLZ
- Class II
- Ongoing
Sep 23, 2026
Z-3169-2026
Centricity PACS Server V7, intended for managing digital medical images and associated data, All versions
GE Healthcare
- LLZ
- Class II
- Ongoing
Sep 23, 2026
Z-3171-2026
Core Services Hub V8, a set of backend services including Cross Enterprise (XE) and Workflow Core (WFC) services that enables enterprise imaging workflows, All…
GE Healthcare
- LLZ
- Class II
- Ongoing
Sep 23, 2026
Z-3166-2026
Centricity Enterprise Archive V2, V3, and V4, software product for receiving, archiving, and sending electronic medical data, All Versions
GE Healthcare
- LLZ
- Class II
- Ongoing
Sep 2, 2026
Z-3004-2026
Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstation
Merge Healthcare, Inc.
- LLZ
- Class II
- Ongoing
Sep 2, 2026
Z-3030-2026
FUJIFILM Synapse PACS software v7.4.310; radiological image processing system
FUJIFILM Healthcare Americas Corporation
- LLZ
- Class II
- Ongoing