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
121–144 of 334
Search insights Median review: 139d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jun 30, 2025
Synapse PACS (7.5)
K243647 · QIH
Fujifilm Healthcare Americas Corporation
Radiology · 216d
Cleared Jun 30, 2025
PIUR tUS inside
K250484 · QIH
Piur Imaging GmbH
Radiology · 131d
Cleared Jun 30, 2025
EchoConfidence (USA)
K250670 · QIH
Mycardium AI Limited
Radiology · 117d
Cleared Jun 13, 2025
Brainlab Elements (7.0)
K243633 · QIH
Brainlab AG
Radiology · 200d
Cleared Jun 10, 2025
Viz Subdural+, Viz SUBDURAL PLUS
K250354 · QIH
Viz. Ai, Inc.
Radiology · 123d
Cleared Jun 06, 2025
Cirrus Resting State fMRI Software
K251009 · QIH
Sora Neuroscience, Inc.
Radiology · 66d
Cleared Jun 05, 2025
BrightHeart View Classifier
K251456 · QIH
Brightheart
Radiology · 24d
Cleared Jun 04, 2025
TraumaCad Neo (1.1)
K243810 · QIH
Brainlab , Ltd.
Radiology · 175d
Cleared May 30, 2025
AudaxCeph Cephalogram Analysis Software
K243005 · QIH
Audax D.O.O.
Radiology · 246d
Cleared May 30, 2025
Opulus™ Lymphoma Precision
K243863 · QIH
Roche Molecular Systems, Inc.
Radiology · 164d
Cleared May 28, 2025
Rapid MLS
K243378 · QIH
Ischemaview, Inc.
Radiology · 210d
Cleared May 28, 2025
CoLumboX
K250367 · QIH
Smart Soft Healthcare AD
Radiology · 107d
Cleared May 23, 2025
Second Opinion® 3D
K243989 · QIH
Pearl, Inc.
Radiology · 148d
Cleared May 23, 2025
Clever One
K250005 · QIH
Ewoosoft Co., Ltd.
Radiology · 141d
Cleared May 21, 2025
Synapse 3D Base Tools (V7.0)
K243762 · QIH
Fujifilm Corporation
Radiology · 166d
Cleared May 14, 2025
Medical Image Post-processing Software (uOmnispace.CT)
K242624 · QIH
Shanghai United Imaging Healthcare...
Radiology · 253d
Cleared May 09, 2025
Second Opinion® BLE
K243230 · QIH
Pearl, Inc.
Radiology · 213d
Cleared May 08, 2025
Clarius Median Nerve AI
K250226 · QIH
Clarius Mobile Health Corp.
Radiology · 101d
Cleared May 07, 2025
BrightHeart View Classifier
K243684 · QIH
Brightheart
Radiology · 159d
Cleared Apr 30, 2025
UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis Program
K250328 · QIH
Canon Medical Systems Corporation
Radiology · 84d
Cleared Apr 16, 2025
LARALAB
K242500 · QIH
Laralab GmbH
Radiology · 237d
Cleared Apr 16, 2025
Clarius Prostate AI
K243853 · QIH
Clarius Mobile Health Corp.
Radiology · 121d
Cleared Apr 11, 2025
GBrain MRI
K250416 · QIH
Galileo Cds, Inc.
Radiology · 57d
Cleared Apr 10, 2025
cmAngio® (V1.6)
K250754 · QIH
Curemetrix, Inc.
Radiology · 29d