FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology ×
15,620 results
2353–2376 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
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
Cleared Apr 14, 2021
BriefCase, RIB Fractures Triage (RibFx)
K202992 · QFM
Aidoc Medical , Ltd.
Radiology · 196d
Cleared Apr 12, 2021
Alphenix, INFX-8000C/B, INFX-8000C/S, V9.2
K210900 · OWB
Canon Medical Systems Corporation
Radiology · 17d
Cleared Apr 12, 2021
Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software -...
K202679 · KPS
Mcgovern Medical School
Radiology · 209d