FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology × Cleared only ×
15,570 results
289–312 of 15,570
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jan 05, 2026
HERA Z20 Diagnostic Ultrasound System
K252018 · IYN
Samsung Medison Co., Ltd.
Radiology · 189d
Cleared Dec 30, 2025
AnyScan 3.0 NM Scanner Family
K253844 · KPS
Mediso Medical Imaging Systems, Ltd.
Radiology · 28d
Cleared Dec 30, 2025
TruSPECT Processing Station
K253532 · QIH
Spectrum Dynamics Medical, Ltd.
Radiology · 47d
Cleared Dec 23, 2025
ART-Plan+ (v3.1.0)
K253091 · MUJ
Therapanacea Sas
Radiology · 91d
Cleared Dec 23, 2025
AIR Recon DL
K252379 · LNH
Ge Medical Systems, LLC
Radiology · 146d
Cleared Dec 23, 2025
Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP)
K251268 · IYN
Edan Instruments, Inc.
Radiology · 243d
Cleared Dec 22, 2025
PeekMed web
K252856 · QIH
Peek Health, S.A.
Radiology · 104d
Cleared Dec 22, 2025
Lumify Diagnostic Ultrasound System
K252557 · IYN
Philips Ultrasound, LLC
Radiology · 131d
Cleared Dec 22, 2025
RayStation (2024A SP3)
K252109 · MUJ
RaySearch Laboratories AB (PUBL)
Radiology · 168d
Cleared Dec 22, 2025
MC2 Portable X-ray System
K252068 · OWB
Oxos Medical
Radiology · 174d
Cleared Dec 22, 2025
BioticsAI
K250959 · IYN
Bioticsai, Inc.
Radiology · 266d
Cleared Dec 19, 2025
ClearCalc Model RADCA V2.6
K252863 · MUJ
Radformation, Inc.
Radiology · 101d
Cleared Dec 19, 2025
MAGNETOM Sola
K252838 · LNH
Siemens Healthcare GmbH
Radiology · 105d
Cleared Dec 19, 2025
LCD Monitor (CL1902A, CL2103F)
K252780 · PGY
Shenzhen Beacon Display Technology...
Radiology · 108d
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