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
2425–2448 of 15,695
Search insights Median review: 81d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared May 06, 2021
Corvus Radiation Therapy Planning System
K211034 · MUJ
Best Nomos
Radiology · 29d
Cleared May 06, 2021
ImagePilot
K210066 · LLZ
Konica Minolta, Inc.
Radiology · 115d
Cleared May 04, 2021
SOTA Cloud Imaging
K210682 · LLZ
Sota Precision Optics, Inc. Dba Sota...
Radiology · 57d
Cleared May 04, 2021
PtoleMedic System
K202521 · LLZ
Lento Medical Innovation, Inc.
Radiology · 245d
Cleared Apr 30, 2021
AcuityDRe
K210919 · MQB
Radmedix, LLC
Radiology · 32d
Cleared Apr 30, 2021
HYPER AiR
K210001 · KPS
Shanghai United Imaging Healthcare...
Radiology · 116d
Cleared Apr 30, 2021
syngo. CT Extended Functionalities
K203699 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 133d
Cleared Apr 28, 2021
1717FCC
K210985 · MQB
Rayence Co., Ltd.
Radiology · 27d
Cleared Apr 28, 2021
AMX Navigate
K210982 · IZL
Ge Medical Systems, LLC
Radiology · 27d
Cleared Apr 28, 2021
Trinias
K203535 · OWB
Shimadzu Corporation Medical Systems
Radiology · 146d
Cleared Apr 28, 2021
TCL3 Motion Tracking System
K203451 · LNH
Tracinnovations Aps
Radiology · 156d
Cleared Apr 23, 2021
2MP Monochrome LCD Monitor MS-S200
K210345 · PGY
Jvckenwood Corporation
Radiology · 77d
Cleared Apr 23, 2021
PlutoX Digital Intraoral X-Ray Imaging System
K210312 · MUH
Iray Technology Taicang , Ltd.
Radiology · 79d
Cleared Apr 23, 2021
MEDO-Thyroid
K203502 · QIH
Medo DX Pte. , Ltd.
Radiology · 144d
Cleared Apr 23, 2021
Cartesion Prime (PCD-1000A/3) V10.8
K203314 · KPS
Canon Medical Systems Corporation
Radiology · 164d
Cleared Apr 21, 2021
Yushan X-Ray Flat Panel Detector with DROC
K210988 · MQB
Innocare Optoelectronics Corp.
Radiology · 20d
Cleared Apr 21, 2021
Preview Shoulder
K210556 · QIH
Genesis Software Innovations
Radiology · 55d
Cleared Apr 20, 2021
Identify
K210835 · IYE
Varian Medical Systems, Inc.
Radiology · 29d
Cleared Apr 20, 2021
Automatic Anatomy Recognition (AAR)
K203610 · QKB
Quantitative Radiology Solutions, LLC
Radiology · 131d
Cleared Apr 19, 2021
AI Segmentation
K203469 · MUJ
Varian Medical Systems, Inc.
Radiology · 145d
Cleared Apr 16, 2021
Saige-Q
K203517 · QFM
DeepHealth, Inc.
Radiology · 137d
Cleared Apr 16, 2021
rainbow CT
K200271 · OAS
Dentium Co., Ltd (Ict Branch)
Radiology · 437d
Cleared Apr 16, 2021
rainbow MCT
K200270 · OAS
Dentium Co., Ltd (Ict Branch)
Radiology · 437d
Cleared Apr 14, 2021
CX30N (CX30PQX)
K210493 · PGY
Wide Corporation
Radiology · 54d