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
193–216 of 334
Search insights Median review: 139d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Sep 06, 2024
uAI Portal
K240411 · QIH
Shanghai United Imaging Intelligence...
Radiology · 207d
Cleared Aug 30, 2024
Imbio PHA (4.0.0)
K241847 · QIH
Imbio, Inc.
Radiology · 65d
Cleared Aug 30, 2024
syngo.via MI Workflows
K242275 · QIH
Siemens Medical Solutions USA, Inc.
Radiology · 29d
Cleared Aug 30, 2024
MI View&GO
K242300 · QIH
Siemens Medical Solutions USA, Inc.
Radiology · 28d
Cleared Aug 27, 2024
Overjet Charting Assist
K241684 · QIH
Overjet, Inc.
Radiology · 77d
Cleared Aug 22, 2024
NeuroQuant
K241098 · QIH
Cortechs Labs, Inc.
Radiology · 122d
Cleared Aug 16, 2024
qCT LN Quant
K240740 · QIH
Qure.Ai Technologies
Radiology · 151d
Cleared Aug 15, 2024
CoLumbo
K241211 · QIH
Smart Soft Healthcare
Radiology · 107d
Cleared Aug 12, 2024
OptimMRI (v2)
K242054 · QIH
Rebrain, Sas
Radiology · 28d
Cleared Aug 08, 2024
i2Contour
K233822 · QIH
Mrimath, LLC
Radiology · 251d
Cleared Aug 05, 2024
AI Platform 2.0 (AIP002)
K240953 · QIH
Exo Imaging
Radiology · 119d
Cleared Jul 12, 2024
RUS
K233457 · QIH
Hutom, Inc.
Radiology · 266d
Cleared Jul 12, 2024
Acorn 3D Software (AC-SEG-4009)
K234009 · QIH
Mighty Oak Medical
Radiology · 206d
Cleared Jul 11, 2024
SubtleSYNTH (1.x)
K241329 · QIH
Subtle Medical, Inc.
Radiology · 62d
Cleared Jul 02, 2024
SMART Bun-Yo-Matic X-Ray
K240736 · QIH
Disior, Ltd.
Radiology · 106d
Cleared Jun 25, 2024
VEA Align
K240582 · QIH
Eos Imaging
Radiology · 116d
Cleared Jun 21, 2024
Medihub Prostate
K233196 · QIH
JLK, Inc.
Radiology · 267d
Cleared Jun 20, 2024
SMART Bun-Yo-Matic CT
K240642 · QIH
Disior, Ltd.
Radiology · 106d
Cleared Jun 14, 2024
SIS System
K241083 · QIH
Surgical Information Sciences, Inc.
Radiology · 56d
Cleared Jun 13, 2024
Relu Creator
K233925 · QIH
Relu BV
Radiology · 183d
Cleared Jun 07, 2024
EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100)
K234042 · QIH
Ever Fortune.Ai, Co., Ltd.
Radiology · 169d
Cleared Jun 07, 2024
Cardiac CT Function Software Application
K241038 · QIH
Circle Cardiovascular Imaging
Radiology · 52d
Cleared May 24, 2024
LVivo IQS
K240769 · QIH
Dia Imaging Analysis, Ltd.
Radiology · 64d
Cleared May 17, 2024
uOmnispace.CT
K233209 · QIH
Shanghai United Imaging Healthcare...
Radiology · 232d