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
841–864 of 15,695
Search insights Median review: 81d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jan 16, 2025
Second Opinion CC
K242522 · MYN
Pearl, Inc.
Radiology · 146d
Cleared Jan 16, 2025
VIVIX-M
K241113 · MUE
Vieworks Co., Ltd.
Radiology · 269d
Cleared Jan 15, 2025
Ziehm Vision RFD
K243328 · OWB
Ziehm Imaging GmbH
Radiology · 83d
Cleared Jan 15, 2025
Cardiac Guidance
K243065 · QJU
Caption Health, Inc.
Radiology · 110d
Cleared Jan 14, 2025
Orthoscan VERSA Mini C-Arm
K243452 · OXO
Ziehm-Orthoscan, Inc.
Radiology · 68d
Cleared Jan 14, 2025
SpectoMed (v1.0)
K242205 · LLZ
Specto Medical
Radiology · 172d
Cleared Jan 14, 2025
uCT 550
K241166 · JAK
Shanghai United Imaging Healthcare...
Radiology · 263d
Cleared Jan 13, 2025
SpotLight/SpotLight Duo with Low Dose Lung Cancer Screening Option
K241200 · JAK
Arineta , Ltd.
Radiology · 258d
Cleared Jan 10, 2025
ScreenDx
K241891 · QWO
Imvaria, Inc.
Radiology · 196d
Cleared Jan 10, 2025
Mould Probe MR Safe
K241764 · JAQ
Varian Medical Systems, Inc.
Radiology · 204d
Cleared Jan 10, 2025
INTRABEAM (700)
K241174 · JAD
Carl Zeiss Meditec, AG
Radiology · 259d
Cleared Jan 09, 2025
Dental Cone-beam Computed Tomography (FinScan F350)
K242805 · OAS
Changzhou Finno Medical Technology...
Radiology · 114d
Cleared Jan 07, 2025
Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit...
K243335 · LNH
Canon Medical Systems Corporation
Radiology · 75d
Cleared Jan 07, 2025
GXR-Series Diagnostic X-Ray System
K242019 · KPR
DRGEM Corporation
Radiology · 181d
Cleared Jan 07, 2025
ApolloHipX (THR.SS.0001)
K241808 · LLZ
Corin U.S.A. Limited
Radiology · 200d
Cleared Jan 07, 2025
uCT 780
K241079 · JAK
Shanghai United Imaging Healthcare...
Radiology · 263d
Cleared Jan 06, 2025
Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E))
K242499 · KPR
Shenzhen?Sontu?Medical?Imaging?Equipm...
Radiology · 137d
Cleared Jan 06, 2025
Soteria E-View
K242488 · JAA
Omega Medical Imaging, LLC
Radiology · 138d
Cleared Jan 06, 2025
Brainomix 360 e-CTA
K242123 · LLZ
Brainomix Limited
Radiology · 171d
Cleared Jan 03, 2025
JLK-ICH
K243363 · QAS
JLK, Inc.
Radiology · 66d
Cleared Jan 03, 2025
INNOVISION-EXII
K242119 · KPR
Dk Medical System
Radiology · 168d
Cleared Jan 03, 2025
syngo.CT Dual Energy
K241757 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 199d
Cleared Jan 03, 2025
Clarify DL
K241350 · LLZ
Ge Medical Systems Israel, Functional...
Radiology · 235d
Cleared Jan 02, 2025
Ezra Flash
K242334 · QIH
Ezra Ai, Inc.
Radiology · 148d