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
385–408 of 15,695
Search insights Median review: 81d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jan 14, 2026
ExacTrac Dynamic (2.0.2)
K254010 · IYE
Brainlab SE
Radiology · 30d
Cleared Jan 14, 2026
Orthoscan TAU MVP Mini C-Arm System
K252579 · OXO
Ziehm-Orthoscan, Inc.
Radiology · 152d
Cleared Jan 13, 2026
VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364)
K254001 · KPS
Spectrum Dynamics Medical, Ltd.
Radiology · 29d
Cleared Jan 08, 2026
3DICOM MD Cloud
K253784 · LLZ
Singular Health Pty, Ltd.
Radiology · 43d
Cleared Jan 08, 2026
View
K253639 · LLZ
Ge Healthcare
Radiology · 50d
Cleared Jan 08, 2026
LOGIQ Totus
K253370 · IYN
GE Medical Systems Ultrasound and...
Radiology · 100d
Cleared Jan 07, 2026
LOGIQ Fortis
K253366 · IYN
GE Medical Systems Ultrasound and...
Radiology · 99d
Cleared Jan 07, 2026
DS Core Detect
K253009 · MYN
Dentsply Sirona, Inc.
Radiology · 110d
Cleared Jan 07, 2026
BriefCase-Triage: CARE Multi-triage CT Body
K252970 · QAS
Aidoc Medical , Ltd.
Radiology · 112d
Cleared Jan 05, 2026
maiLink
K253008 · LLZ
Maihub Corp.
Radiology · 108d
Cleared Jan 05, 2026
ChartCheck (RADCH V1.6)
K252988 · IYE
Radformation, Inc.
Radiology · 109d
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