Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Radiology × Cleared only ×
15,676 results
1–24 of 15,676
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Oct 30, 2026
EFAI NEUROSUITE CTA LVO ASSESSMENT SYSTEM (LVO-CTA-100)
K263109 · QAS
Ever Fortune.Ai, Co., Ltd.
Radiology · 56d
Cleared Oct 30, 2026
DS Core Detect
K261072 · MYN
Dentsply Sirona, Inc.
Radiology · 212d
Cleared Oct 30, 2026
AutoGel Pad (400-046,400-005)
K260575 · MUI
Top-Rank Health Care Co., Ltd.
Radiology · 252d
Cleared Oct 29, 2026
Vitrea Advanced Visualization, Version 7.16
K263648 · LLZ
Canon Medical Informatics, Inc.
Radiology · 27d
Cleared Oct 28, 2026
uPMR Zenith
K261676 · OUO
Shanghai United Imaging Healthcare...
Radiology · 160d
Cleared Oct 27, 2026
OsteoSight Spine (v1)
K261512 · SAO
Naitive Technologies, Ltd.
Radiology · 173d
Cleared Oct 26, 2026
MIM – KineticID
K261763 · LLZ
Mim Software, Inc.
Radiology · 151d
Cleared Oct 23, 2026
BlineSlide
K261679 · POK
Deep Breathe, Inc.
Radiology · 155d
Cleared Oct 21, 2026
Eden PACS
K261788 · LLZ
Higia., Inc. d/b/a Eden
Radiology · 145d
Cleared Oct 21, 2026
PV-iCurve Pro
K261531 · LLZ
Perception Vision Medical Technology...
Radiology · 166d
Cleared Oct 20, 2026
Accuro XV
K262093 · IYO
Rivanna Medical, Inc.
Radiology · 120d
Cleared Oct 20, 2026
CINA-Aneurysm
K262062 · QBS
Avicenna.Ai
Radiology · 124d
Cleared Oct 19, 2026
CINA-Aneurysm+
K262147 · QIH
Avicenna.Ai
Radiology · 116d
Cleared Oct 19, 2026
VenusCT
K260510 · SFV
Linatech, LLC
Radiology · 244d
Cleared Oct 16, 2026
Diagnostic Ultrasound System (Nuewa A20W)
K261585 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 156d
Cleared Oct 16, 2026
Lilium one (USM330)
K260605 · IYO
Lilium Otsuka Co., Ltd.
Radiology · 234d
Cleared Oct 16, 2026
AVIEW Aorta Metrics
K260391 · JAK
Coreline Soft Co., Ltd.
Radiology · 252d
Cleared Oct 09, 2026
ECHELON Synergy
K262902 · LNH
Fujifilm Corporation
Radiology · 52d
Cleared Oct 09, 2026
Rapid ICH (v4.0)
K262301 · QAS
Ischemaview, Inc.
Radiology · 94d
Cleared Oct 08, 2026
V10 Diagnostic Ultrasound System
K263150 · IYN
Samsung Medison Co., Ltd.
Radiology · 30d
Cleared Oct 08, 2026
Diagnostic Ultrasound System (Resona I10W)
K261617 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 146d
Cleared Oct 07, 2026
NeuroDR
K262134 · QIH
Deep Reasoning Ai, Inc.
Radiology · 104d
Cleared Oct 07, 2026
Ligence Heart
K261733 · QIH
UAB Ligence
Radiology · 134d
Cleared Oct 07, 2026
Vista AI Scan
K260092 · LNH
Vista AI, Inc.
Radiology · 268d