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: QIH ×
334 results
25–48 of 334
Search insights Median review: 139d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jul 24, 2026
DIANA
K260192 · QIH
ROPCA ApS
Radiology · 183d
Cleared Jul 24, 2026
SwiftMR
K261349 · QIH
Airs Medical, Inc.
Radiology · 91d
Cleared Jul 23, 2026
VELMENI for DENTISTS (V4D) 3D
K254096 · QIH
Velmeni, Inc.
Radiology · 216d
Cleared Jul 20, 2026
Hi-D Imaging 4TAVR
K261535 · QIH
Hi-D Imaging AG
Radiology · 73d
Cleared Jul 15, 2026
SkeletonPlanner
K260206 · QIH
UPlanner B.V. - Presurgeo
Radiology · 173d
Cleared Jul 07, 2026
InferOperate Suite
K260973 · QIH
Beijing Infervision Healthcare...
Radiology · 105d
Cleared Jun 25, 2026
syngo.CT Coronary Cockpit
K253786 · QIH
Siemens Medical Solutions USA, Inc.
Radiology · 211d
Cleared Jun 18, 2026
Synapse PACS (7.6.0)
K261713 · QIH
Fujifilm Healthcare Americas Corporation
Radiology · 27d
Cleared Jun 15, 2026
MediAI-OA
K253172 · QIH
Crescom Co., Ltd.
Radiology · 262d
Cleared Jun 15, 2026
LungMaps
K253690 · QIH
Siemens Healthineers AG
Radiology · 206d
Cleared CT Jun 15, 2026
WatchMate Software
K260300 · QIH
Anumana, Inc.
Radiology · 136d
Cleared Jun 12, 2026
Brainomix 360 Hyperdensity
K260406 · QIH
Brainomix Limited
Radiology · 123d
Cleared Jun 11, 2026
Acorn 3D Software (AC-SEG-4009)
K260322 · QIH
Mighty Oak Medical
Radiology · 132d
Cleared Jun 04, 2026
DEEPVESSEL Plaque
K260497 · QIH
Keya Medical Technology Co., Ltd.
Radiology · 111d
Cleared May 29, 2026
OrthoGrid Hip AI® 4.0
K260077 · QIH
OrthoGrid Systems, Inc.
Radiology · 137d
Cleared May 28, 2026
ANDI 2.2
K261405 · QIH
Imeka Solutions, Inc.
Radiology · 29d
Cleared May 22, 2026
Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning
K260324 · QIH
Canon Medical Informatics, Inc.
Radiology · 112d
Cleared May 21, 2026
BAC
K254131 · QIH
DeepHealth, Inc.
Radiology · 150d
Cleared CT May 21, 2026
MSK Go
K260234 · QIH
Smart Alfa Teknoloji San. Ve Tic. A.S.
Radiology · 115d
Cleared May 15, 2026
Neurophet SCALE PET
K252563 · QIH
Neurophet., Inc.
Radiology · 274d
Cleared May 15, 2026
SubtleHD-CT (1.x)
K254120 · QIH
Subtle Medical, Inc.
Radiology · 147d
Cleared May 15, 2026
Neurophet AQUA
K261273 · QIH
Neurophet., Inc.
Radiology · 28d
Cleared May 15, 2026
UNiD™ Spine Analyzer (SW3002)
K261289 · QIH
Medicrea International S.A.S....
Radiology · 25d
Cleared May 13, 2026
Morph
K260032 · QIH
BeauBrain Healthcare, Inc.
Radiology · 127d