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
25–48 of 15,695
Search insights Median review: 81d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Oct 05, 2026
InkSpace Imaging Small Body Array (SBA12PH15x)
K262813 · MOS
Inkspace Imaging, Inc.
Radiology · 59d
Cleared Oct 05, 2026
RT Elements (4.6)
K261655 · MUJ
Brainlab SE
Radiology · 139d
Cleared Oct 05, 2026
QGuideCT (1.0)
K260523 · QIH
Medis Medical Imaging Systems BV
Radiology · 230d
Cleared Oct 02, 2026
Medical Monitor (32MD08WC)
K262985 · PGY
Lg Electronics.Inc
Radiology · 36d
Cleared Oct 02, 2026
Coronis Fusion 4MP (MDCC-4630)
K262412 · PGY
Barco NV
Radiology · 79d
Cleared Oct 02, 2026
REMEX-T(K)100C
K261943 · IZL
Remedi, Inc.
Radiology · 114d
Cleared Oct 02, 2026
Voluson Expert 18
K261933 · IYN
GE Medical Systems Ultrasound and...
Radiology · 115d
Cleared Oct 02, 2026
Lung Guidance
K261042 · QJU
GE Medical Systems Ultrasound &...
Radiology · 185d
Cleared Oct 01, 2026
SwiftSight-BodyComposition
K261612 · LNH
Airs Medical, Inc.
Radiology · 139d
Cleared Sep 30, 2026
Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3)...
K263033 · OAS
Fussen Technology Co., Ltd.
Radiology · 30d
Cleared Sep 30, 2026
EzSensor HD
K261663 · MUH
Qpix Solutions, Inc.
Radiology · 133d
Cleared Sep 29, 2026
Syngo Carbon Space (VA4)
K263048 · LLZ
Siemens Healthineers AG
Radiology · 29d
Cleared Sep 29, 2026
CAS-One IR
K261225 · JAK
Cascination AG
Radiology · 167d
Cleared Sep 25, 2026
EVO X30 Diagnostic Ultrasound System
K263182 · IYN
Samsung Medison Co., Ltd.
Radiology · 14d
Cleared Sep 25, 2026
EPIQ Inspira Series Diagnostic Ultrasound System
K262548 · IYN
Philips Ultrasound, LLC
Radiology · 64d
Cleared Sep 25, 2026
syngo.CT Brain Quantification
K260055 · QIH
Siemens Medical Solutions USA, Inc.
Radiology · 260d
Cleared Sep 24, 2026
MD-6000S Bladder Scanner
K260313 · IYO
MEDA Co., Ltd.
Radiology · 237d
Cleared Sep 24, 2026
Align® Cover and Pad Guidance Tool
K260114 · ITX
CIVCO Medical Instruments Co., Inc.
Radiology · 253d
Cleared Sep 23, 2026
Syneris PACS v.1.0.1.0
K261874 · LLZ
Syneris
Radiology · 110d
Cleared Sep 23, 2026
VIRTUE QA
K260597 · LHN
ProNova Solutions
Radiology · 211d
Cleared Sep 22, 2026
HipStudio Analysis
K262442 · LLZ
Replasia BV
Radiology · 68d
Cleared Sep 22, 2026
BoneXpert
K262390 · QIH
Visiana
Radiology · 71d
Cleared Sep 22, 2026
BodyTom 64 (NL4100)
K261125 · JAK
Samsung HME America, Inc., dba...
Radiology · 169d
Cleared Sep 21, 2026
Rapid Platform (R6.7)
K261368 · QIH
Ischemaview, Inc.
Radiology · 147d