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
1561–1584 of 15,695
Search insights Median review: 81d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared May 23, 2023
uMR Omega
K230152 · LNH
Shanghai United Imaging Healthcare...
Radiology · 124d
Cleared May 23, 2023
Genius AI Detection 2.0 with CC-MLO Correlation
K230096 · QDQ
Hologic, Inc.
Radiology · 130d
Cleared May 22, 2023
TrueBeam, TrueBeam STx, Edge, VitalBeam
K223839 · IYE
Varian Medical Systems, Inc.
Radiology · 151d
Cleared May 19, 2023
VirtuOst
K220402 · KGI
O.N. Diagnostics
Radiology · 462d
Cleared May 19, 2023
Autoplaque
K212758 · LLZ
Cedars-Sinai Medical Center: Aim
Radiology · 626d
Cleared May 18, 2023
uMR 570
K230758 · LNH
Shanghai United Imaging Healthcare...
Radiology · 59d
Cleared May 18, 2023
C510G/JUSHA-C510G/C510/JUSHA- C510 LCD Monitor
K230723 · PGY
Nanjing Jusha Display Technology Co.,...
Radiology · 63d
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