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
577–600 of 15,695
Search insights Median review: 81d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Aug 06, 2025
InVision™ 3T Recharge Operating Suite
K252239 · LNH
Imris Imaging, Inc.
Radiology · 20d
Cleared Aug 06, 2025
Digital Radiographic Imaging Acquisition Software - DR (RiasDR)
K251038 · LLZ
Shen Zhen Cambridge-Hit Co., Ltd.
Radiology · 125d
Cleared Aug 05, 2025
uMR Jupiter
K250246 · LNH
Shanghai United Imaging Healthcare...
Radiology · 190d
Cleared Aug 05, 2025
iPETcertum (v1.0)
K244016 · LLZ
Claritas Healthtech Pte, Ltd.
Radiology · 221d
Cleared Aug 04, 2025
HnX-P1, HnX-PB
K251223 · IZL
H&abyz Co., Ltd.
Radiology · 105d
Cleared Aug 01, 2025
Revolution Vibe
K250941 · JAK
Ge Medical Systems, LLC
Radiology · 126d
Cleared Aug 01, 2025
INNOVISION-DXII
K250790 · KPR
Dk Medical Systems Co., Ltd.
Radiology · 140d
Cleared Aug 01, 2025
Deepsight NeedleVue LC1 Ultrasound System
K250381 · IYO
DeepSight Technology, Inc.
Radiology · 171d
Cleared Jul 31, 2025
Biograph Trinion
K251561 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 71d
Cleared Jul 31, 2025
YSIO X.pree
K250738 · KPR
Siemens Medical Solutions
Radiology · 142d
Cleared Jul 31, 2025
REMEX Xcam6
K250597 · IZL
Remedi, Inc.
Radiology · 153d
Cleared Jul 31, 2025
Genius AI Detection 2.0
K243341 · QDQ
Hologic, Inc.
Radiology · 279d
Cleared Jul 30, 2025
Voxel Dosimetry (00859873006226)
K243919 · QIH
Hermes Medical Solutions AB
Radiology · 222d
Cleared Jul 29, 2025
Cios Spin
K251523 · OWB
Siemens Medical Solutions USA, Inc.
Radiology · 74d
Cleared Jul 29, 2025
PRORAD ATLAS ULTRAPORTABLE
K243473 · IZL
Prognosys Medical Systems Private...
Radiology · 263d
Cleared Jul 28, 2025
NAEOTOM Alpha.Peak/NAEOTOM Alpha
K251061 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 115d
Cleared Jul 25, 2025
Venue
K251322 · IYN
GE Medical Systems Ultrasound and...
Radiology · 87d
Cleared Jul 25, 2025
Marie
K250970 · JAK
Leo Cancer Care
Radiology · 116d
Cleared Jul 24, 2025
EPIQ Series Diagnostic Ultrasound System
K251455 · IYN
Philips Ultrasound, LLC
Radiology · 73d
Cleared Jul 23, 2025
IMAGE ONE
K250716 · LLZ
Infomed Software, S.L.
Radiology · 135d
Cleared Jul 23, 2025
Neuro Insight V1.0
K243681 · LLZ
Olea Medical S.A.S.
Radiology · 236d
Cleared Jul 22, 2025
Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction...
K250901 · LNH
Canon Medical Systems Corporation
Radiology · 118d
Cleared Jul 22, 2025
GyriCalc (Version 1.0.0)
K250686 · LLZ
Neurospectrum Insights Corp.
Radiology · 138d
Cleared Jul 22, 2025
Yushan X-Ray Flat Panel Detector
K250211 · MQB
Innocare Optoelectronics Corp.
Radiology · 179d