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
4465–4488 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Dec 11, 2015
DR 600
K152639 · MQB
Agfa Healthcare N.V.
Radiology · 87d
Cleared Dec 11, 2015
Panther StereoSeed
K143514 · MUJ
Prowess, Inc.
Radiology · 365d
Cleared Dec 10, 2015
PAPAYA 3D Plus
K150354 · OAS
Genoray Co., Ltd.
Radiology · 302d
Cleared Dec 09, 2015
Touch Ultrasound
K152467 · IYN
Carestream Health, Inc.
Radiology · 100d
Cleared Dec 04, 2015
kVue Encompass SRS Insert (Encompass Insert), Encompass SRS Standalone...
K152321 · IYE
Qfix
Radiology · 109d
Cleared Dec 04, 2015
Implant Studio 2015
K152078 · LLZ
3Shape Medical A/S
Radiology · 130d
Cleared Dec 03, 2015
Portable X-ray System (Model: MINIX-V / MINIX-S)
K152859 · EHD
Digimed Co., Ltd. (Digimed...
Radiology · 64d
Cleared Nov 27, 2015
Aquilion ONE Vision with FIRST 1.0 (CCRS-001A)
K151673 · JAK
Toshibamedical Systems Corporation
Radiology · 158d
Cleared Nov 25, 2015
Carestream DRX-1 System with DRX Plus 4343 Detectors
K153142 · MQB
Carestream Health, Inc.
Radiology · 26d
Cleared Nov 25, 2015
VidiStar HeartView
K152822 · LLZ
Vidistar, LLC
Radiology · 58d
Cleared Nov 25, 2015
XIDF-AWS801, Angio Workstation, V6.20
K152785 · OWB
Toshibamedical Systems Corporation
Radiology · 61d
Cleared Nov 25, 2015
Permanent Beacon Transponder, Soft Tissue Beacon Transponder, Beacon Care...
K152761 · IYE
Varian Medical Systems, Inc.
Radiology · 62d
Cleared Nov 25, 2015
4Sight
K152573 · IYO
Accutome, Inc.
Radiology · 77d
Cleared Nov 25, 2015
CORVUS Radiation Therapy Planning System
K151469 · MUJ
Best Nomos
Radiology · 177d
Cleared Nov 24, 2015
SOMATOM Force, SOMATOM Definition Flash, SOMATOM Definition Edge, SOMATOM...
K142955 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 406d
Cleared Nov 20, 2015
8MP Color LCD Monitor, RadiForce RX850, RX850-AR
K152713 · PGY
Eizo Corporation
Radiology · 60d
Cleared Nov 20, 2015
IQQA Guide
K151414 · JAK
Edda Technology
Radiology · 177d
Cleared Nov 20, 2015
ArcCHECK
K142617 · IYE
Sun Nuclear Corporation
Radiology · 430d
Cleared Nov 19, 2015
BladderScan Prime System
K153101 · IYO
Verathon Incorporated
Radiology · 24d
Cleared Nov 18, 2015
Philips IntelliSpace Cardiovascular
K153022 · LLZ
Philips Medical Systems Nethrlands BV
Radiology · 34d
Cleared Nov 18, 2015
Venue 50
K152758 · IYN
GE Medical Systems Ultrasound and...
Radiology · 55d
Cleared Nov 18, 2015
8 CH Knee SPEEDER
K152695 · MOS
Quality Electrodynamics, LLC
Radiology · 58d
Cleared Nov 17, 2015
DIVA ZSP5812CMI with QUBYX PerfectLum bundle
K152847 · PGY
Qubyx , Ltd.
Radiology · 49d
Cleared Nov 17, 2015
MD-2300S Ultrasonic A/B Scanner for Ophthalmology
K152318 · IYO
MEDA Co., Ltd.
Radiology · 92d