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
1129–1152 of 15,676
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared May 16, 2024
HD80 Series Ultrasound Diagnostic System
K233841 · IYN
Qingdao Hisense Medical Equipment...
Radiology · 164d
Cleared May 15, 2024
BriefCase-Quantification
K241112 · QIH
Aidoc Medical , Ltd.
Radiology · 23d
Cleared May 15, 2024
Heuron ICH
K233247 · QAS
Heuron Co., Ltd.
Radiology · 230d
Cleared May 13, 2024
REMEX-GR100
K240759 · EHD
Remedi Co., Ltd.
Radiology · 54d
Cleared May 13, 2024
Brainomix 360 e-Lung
K233875 · JAK
Brainomix Limited
Radiology · 158d
Cleared May 13, 2024
MIM – Monte Carlo Dosimetry
K232862 · LLZ
Mim Software, Inc.
Radiology · 241d
Cleared May 10, 2024
APERTO Lucent MRI System
K233629 · LNH
Fujifilm Healthcare Americas Corporation
Radiology · 179d
Cleared May 10, 2024
SmartChest
K232410 · QFM
Milvue
Radiology · 274d
Cleared May 09, 2024
Flexible Fixation Device for Gynecological Applicators (GM11001960)
K240495 · JAQ
Varian Medical Systems, Inc.
Radiology · 79d
Cleared May 09, 2024
VUZE System
K232976 · LLZ
Vuze Medical , Ltd.
Radiology · 231d
Cleared May 07, 2024
DeepContour (V1.0)
K232928 · QKB
Wisdom Technologies., Inc.
Radiology · 230d
Cleared May 07, 2024
Eve Patient Positioner System
K231612 · JAI
Leo Cancer Care
Radiology · 340d
Cleared May 06, 2024
MIM – Dose Analysis
K232514 · LLZ
Mim Software, Inc.
Radiology · 262d
Cleared May 03, 2024
ECHELON Synergy V10.0
K233687 · LNH
Fujifilm Healthcare Americas Corporation
Radiology · 168d
Cleared May 03, 2024
B-Ultrasound Diagnostic System
K232895 · IYO
Contec Medical Systems Co.,Ltd
Radiology · 228d
Cleared May 03, 2024
CT 5300
K232491 · JAK
Philips Healthcare (Suzhou) Co., Ltd.
Radiology · 260d
Cleared May 02, 2024
Color Doppler Ultrasound Diagnostic System (CMS1700B), Color Doppler...
K232908 · IYN
Contec Medical Systems Co.,Ltd
Radiology · 226d
Cleared Apr 30, 2024
Ethos Treatment Management (3.0)
K232923 · IYE
Varian Medical Systems, Inc.
Radiology · 224d
Cleared Apr 29, 2024
SubtleREFORMAT (1.x)
K233699 · LLZ
Subtle Medical, Inc.
Radiology · 164d
Cleared Apr 26, 2024
Sonio Detect
K240406 · IYN
Sonio
Radiology · 77d
Cleared Apr 26, 2024
uMR Jupiter
K233673 · LNH
Shanghai United Imaging Healthcare...
Radiology · 162d
Cleared Apr 26, 2024
FCT iSTREAM Phase 1
K233583 · JAK
Fujifilm Healthcare Americas Corporation
Radiology · 171d
Cleared Apr 26, 2024
syngo.via RT Image Suite
K232799 · MUJ
Siemens Medical Solutions USA, Inc.
Radiology · 227d
Cleared Apr 26, 2024
Pocket III
K232302 · IYO
Quantel Medical
Radiology · 269d