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 × Cleared only ×
15,676 results
1561–1584 of 15,676
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared May 17, 2023
Symbia Pro.specta VA20A Family
K231102 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 29d
Cleared May 17, 2023
Radiation Planning Assistant (RPA)
K222728 · MUJ
University of Texas, MD Anderson...
Radiology · 251d
Cleared May 12, 2023
EPIQ Series Diagnostic Ultrasound System
K231190 · IYN
Philips Ultrasound, LLC
Radiology · 16d
Cleared May 12, 2023
RadiForce MX217
K230684 · PGY
Eizo Corporation
Radiology · 60d
Cleared May 12, 2023
iTFlow
K222854 · LLZ
Cardio Flow Design, Inc.
Radiology · 233d
Cleared May 12, 2023
Intraoperative Ultrasound Probe Cover
K222460 · ITX
Exact Medical Manufacturing
Radiology · 270d
Cleared May 11, 2023
ExacTrac Dynamic 1.1.2
K231052 · IYE
Brainlab AG
Radiology · 28d
Cleared May 11, 2023
SubtleMR (2.3.x)
K223623 · LLZ
Subtle Medical, Inc.
Radiology · 157d
Cleared May 10, 2023
Akunah REFLECT
K222987 · LLZ
Akunah Pty, Ltd.
Radiology · 224d
Cleared May 10, 2023
Neurophet AQUA
K220437 · LLZ
Neurophet., Inc.
Radiology · 448d
Cleared May 09, 2023
CX50N
K222719 · PGY
Wide Corporation
Radiology · 243d
Cleared May 08, 2023
MX50N
K222716 · PGY
Wide Corporation
Radiology · 242d
Cleared May 04, 2023
Auto Segmentation
K230082 · QKB
Ge Medical Systems, LLC
Radiology · 113d
Cleared May 04, 2023
Lumify Diagnostic Ultrasound System
K223771 · IYN
Philips Ultrasound
Radiology · 139d
Cleared May 03, 2023
Epione
K223758 · JAK
Quantum Surgical Sas
Radiology · 139d
Cleared May 02, 2023
SIS System
K230977 · QIH
Surgical Information Sciences, Inc.
Radiology · 27d
Cleared May 02, 2023
3D Anatomic Model
K230119 · LLZ
Ricoh USA, Inc.
Radiology · 105d
Cleared May 01, 2023
CP620G LCD monitor, CP620 LCD monitor
K230643 · PGY
Nanjing Jusha Display Technology Co.,...
Radiology · 54d
Cleared May 01, 2023
CarnaLife Holo
K221870 · LLZ
Medapp S.A.
Radiology · 307d
Cleared Apr 28, 2023
Ingenia Elition and MR 7700 MR Systems
K230972 · LNH
Philips Medical Systems Nederland B.V.
Radiology · 23d
Cleared Apr 28, 2023
VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364)
K230600 · KPS
Spectrum Dynamics Medical, Ltd.
Radiology · 56d
Cleared Apr 28, 2023
Nanox.ARC
K222934 · IZF
Nano-X Imaging , Ltd.
Radiology · 214d
Cleared Apr 27, 2023
32HL512D, 31HN713D, 32HQ713D
K230845 · PGY
Lg Electronics.Inc
Radiology · 30d
Cleared Apr 27, 2023
Precision DL
K223212 · KPS
Ge Healthcare
Radiology · 192d