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
409–432 of 15,676
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Dec 19, 2025
Alzevita
K252670 · QIH
TOPIA MEDTECH LIMITED
Radiology · 116d
Cleared Dec 19, 2025
AI-CVD
K252029 · QIH
HeartLung Corporation
Radiology · 172d
Cleared Dec 19, 2025
Rectal Applicator
K251037 · JAQ
Nucletron B.V.
Radiology · 260d
Cleared Dec 19, 2025
Airbile-100
K250976 · IZL
Poskom Co., Ltd.
Radiology · 263d
Cleared Dec 18, 2025
PVAD IQ Software
K252235 · QIH
Ultrasight , Ltd.
Radiology · 154d
Cleared Dec 18, 2025
RefleXion Medical Radiotherapy System, Reflexion X2
K252071 · QVA
Reflexion Medical, Inc.
Radiology · 170d
Cleared Dec 18, 2025
MediAI-BA
K250914 · QIH
Crescom Co., Ltd.
Radiology · 266d
Cleared Dec 17, 2025
Neosoma Brain Mets
K252922 · QIH
Neosoma, Inc.
Radiology · 93d
Cleared Dec 17, 2025
UltraSight Guidance
K251416 · QJU
Ultrasight , Ltd.
Radiology · 224d
Cleared Dec 16, 2025
IDENTIFY (5.0)
K252919 · IYE
Varian Medical Systems, Inc.
Radiology · 95d
Cleared Dec 16, 2025
SKAN C PULSAR
K251893 · OWB
Skanray Technologies Limited
Radiology · 179d
Cleared Dec 16, 2025
IRISeg
K251763 · QIH
Intuitive Surgical, Inc.
Radiology · 190d
Cleared Dec 12, 2025
Swoop® Portable MR Imaging® System
K253489 · LNH
Hyperfine, Inc.
Radiology · 49d
Cleared Dec 11, 2025
CogNet AI-MT+
K252482 · QFM
Medcognetics, Inc.
Radiology · 126d
Cleared Dec 11, 2025
MIM – LesionID Pro
K251883 · LLZ
Mim Software, Inc.
Radiology · 174d
Cleared Dec 09, 2025
Allia Moveo
K251199 · OWB
GE Medical Systems SCS
Radiology · 235d
Cleared Dec 08, 2025
Fetal EchoScan (v1.2)
K252294 · POK
Brightheart
Radiology · 138d
Cleared Dec 05, 2025
Digital Color Doppler Ultrasound System (X11 Exp/X11 Elite/X11 Pro/X11...
K252498 · IYN
Sonoscape Medical Corp.
Radiology · 119d
Cleared Dec 05, 2025
OncoPatch
K252296 · KXK
Oncopatch, Inc.
Radiology · 135d
Cleared Dec 05, 2025
Overjet CBCT Assist
K251514 · QIH
Overjet, Inc.
Radiology · 203d
Cleared Dec 05, 2025
ARTAssistant
K250780 · QKB
Manteia Technologies Co., Ltd.
Radiology · 266d
Cleared Dec 04, 2025
ASUS Ultrasound Imaging System (LU800 series)
K250791 · IYN
Asustek Computer, Inc.
Radiology · 265d
Cleared Dec 03, 2025
Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus...
K251601 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 190d
Cleared Dec 03, 2025
AVIEW Lung Nodule CAD
K251203 · OEB
Coreline Soft Co., Ltd.
Radiology · 229d