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 ×
15,695 results
1657–1680 of 15,695
Search insights Median review: 81d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Mar 03, 2023
DHX-70H, XTG-70H
K221587 · EHD
Digimed Co., Ltd.
Radiology · 275d
Cleared Mar 02, 2023
AccuFFRangio Plus
K230303 · QHA
ArteryFlow Technology Co., Ltd.
Radiology · 27d
Cleared Mar 02, 2023
FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630)
K223902 · IYO
Echosens
Radiology · 64d
Cleared Mar 02, 2023
1.5T 24E Posterior Array
K223203 · LNH
Shenzhen RF Tech Co., Ltd.
Radiology · 139d
Cleared Mar 02, 2023
Rapid NCCT Stroke
K222884 · QAS
Ischemaview, Inc.
Radiology · 161d
Cleared Mar 02, 2023
BoneView
K222176 · QBS
Gleamer
Radiology · 223d
Cleared Mar 01, 2023
32HQ713D
K223423 · PGY
Lg Electronics.Inc
Radiology · 107d
Cleared Mar 01, 2023
Advantis Platform
K222975 · LLZ
Advantis Medical Imaging Single...
Radiology · 154d
Cleared Mar 01, 2023
Xeleris V Processing and Review System
K221680 · LLZ
Ge Healthcare
Radiology · 265d
Cleared Feb 28, 2023
AccuICAS
K221711 · QHA
ArteryFlow Technology Co., Ltd.
Radiology · 260d
Cleared Feb 24, 2023
Clarus Viewer
K222757 · LLZ
Clarus Viewer Corporation
Radiology · 165d
Cleared Feb 24, 2023
AVIEW Lung Nodule CAD
K221592 · OEB
Coreline Soft Co., Ltd.
Radiology · 267d
Cleared Feb 24, 2023
RealNow
K213891 · LLZ
Yiwei Medical Technology Co., Ltd.
Radiology · 437d
Cleared Feb 24, 2023
MAGNETOM Vida
K213805 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 445d
Not Cleared Feb 24, 2023
Caption Interpretation Automated Ejection Fraction Software
DEN220063 · QVD
Caption Health, Inc.
Radiology · 149d
Cleared Feb 23, 2023
Jumong General
K230241 · KPR
Sg Healthcare Co, Ltd.
Radiology · 24d
Cleared Feb 23, 2023
Monaco RTP System
K223233 · MUJ
Elekta Solutions AB
Radiology · 127d
Cleared Feb 23, 2023
MOSAIQ® OIS (Oncology Information System)
K223229 · IYE
Elekta Solutions AB
Radiology · 128d
Cleared Feb 23, 2023
Elekta Unity
K223209 · IYE
Elekta Solutions AB
Radiology · 129d
Cleared Feb 23, 2023
Brainomix 360 e-ASPECTS
K221564 · POK
Brainomix Limited
Radiology · 268d
Cleared Feb 22, 2023
Swoop® Portable MR Imaging System™
K230208 · LNH
Hyperfine, Inc.
Radiology · 28d
Cleared Feb 22, 2023
BoneMRI v1.6
K230197 · QIH
Mriguidance B.V.
Radiology · 28d
Cleared Feb 22, 2023
3D-RD-S
K212587 · IYX
Radiopharmaceutical Imaging and...
Radiology · 555d
Cleared Feb 21, 2023
NEONA 1.5T MRI System
K222259 · LNH
Time Medical Limited
Radiology · 208d