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
1–24 of 334
Search insights Median review: 139d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Oct 19, 2026
CINA-Aneurysm+
K262147 · QIH
Avicenna.Ai
Radiology · 116d
Cleared Oct 07, 2026
Ligence Heart
K261733 · QIH
UAB Ligence
Radiology · 134d
Cleared Oct 07, 2026
NeuroDR
K262134 · QIH
Deep Reasoning Ai, Inc.
Radiology · 104d
Cleared Oct 05, 2026
QGuideCT (1.0)
K260523 · QIH
Medis Medical Imaging Systems BV
Radiology · 230d
Cleared Sep 25, 2026
syngo.CT Brain Quantification
K260055 · QIH
Siemens Medical Solutions USA, Inc.
Radiology · 260d
Cleared Sep 22, 2026
BoneXpert
K262390 · QIH
Visiana
Radiology · 71d
Cleared Sep 21, 2026
Rapid Platform (R6.7)
K261368 · QIH
Ischemaview, Inc.
Radiology · 147d
Cleared Sep 16, 2026
EchoPAC Software Only / EchoPAC Plug-in (v211)
K261623 · QIH
GE Medical Systems Ultrasound and...
Radiology · 124d
Cleared Sep 15, 2026
Artificial Intelligence Renal Assessment (AIRA) Version 1
K261677 · QIH
Aramis Global AI Consultancies, LLC
Radiology · 117d
Cleared Sep 10, 2026
4DM
K260879 · QIH
INVIA, LLC
Radiology · 177d
Cleared Sep 10, 2026
Quicktome Software Suite
K261795 · QIH
Omniscient Neurotechnology Pty, Ltd.
Radiology · 104d
Cleared Sep 09, 2026
ReVISION 2
K251417 · QIH
Argus Cognitive, Inc.
Radiology · 490d
Cleared Sep 04, 2026
NextMR Spine
K260525 · QIH
MRI2CT, Inc.
Radiology · 199d
Cleared Aug 26, 2026
Heartvue.Proton
K260811 · QIH
Heartvue.ai, Inc.
Radiology · 167d
Cleared Aug 25, 2026
Ceevra Reveal 4
K261595 · QIH
Ceevra, Inc.
Radiology · 103d
Cleared Aug 21, 2026
BoneMRI
K260584 · QIH
Mriguidance B.V.
Radiology · 182d
Cleared Aug 21, 2026
DS Core CBCT Anatomy
K262127 · QIH
Dentsply Sirona
Radiology · 58d
Cleared Aug 18, 2026
Lower Limb AI (LLAI)
K261641 · QIH
AI Planning Logic, Inc.
Radiology · 92d
Cleared Aug 10, 2026
Prostate Core
K253794 · QIH
Lucida Medical, Ltd.
Radiology · 255d
Cleared Aug 07, 2026
mdprostate
K252571 · QIH
Mediaire GmbH
Radiology · 358d
Cleared Aug 04, 2026
RealGUIDE
K253902 · QIH
3DIEMME SRL
Radiology · 242d
Cleared Jul 31, 2026
Affinity
K253835 · QIH
Hermes Medical Solutions AB
Radiology · 242d
Cleared Jul 30, 2026
cmAngio® V2.0
K260980 · QIH
Curemetrix, Inc.
Radiology · 127d
Cleared Jul 29, 2026
Cleerly Plaque
K261210 · QIH
Cleerly, Inc.
Radiology · 106d