FDA.report

510(k) K254237

Device
CCI PACS VIEWER (PACS-US-001)
Applicant
CliniComp, Intl.
510(k) number
K254237
Product code
LLZ
Decision
Substantially Equivalent (SESE)
Decision date
2026-04-23
Date received
2025-12-29
Regulation
892.2050
Classification name
System, Image Processing, Radiological
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Dessi Lyakov
Address
9655 Towne Centre Dr. San Diego CA US 92121 92121

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

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K253950Avatar Medical VisionAvatar Medical2026-03-30
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K260479TheraSphere 360™ Y-90 Management PlatformBoston Scientific Corporation2026-03-13
K253111Aeka ImagingGood Methods Global, Inc.2026-03-13
K251964Mimics Thoracic PlannerMaterialise NV2026-03-12
K253486SKIA-Head (Model: SKIA-ST00)Skia, Inc.2026-02-23
K260205AS Software Version AseraAS Software, LLC2026-02-19
K253927LiveMedica Enterprise PACSLive Medica, LLC2026-02-06
K251577LAIA XRAugmented Reality Software S.L.2026-02-06
K2537843DICOM MD CloudSingular Health Pty, Ltd.2026-01-08