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
2857–2880 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Feb 14, 2020
Biograph Vision, Biograph mCT Family of PET/CTs
K193248 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 81d
Cleared Feb 14, 2020
Affinity
K193152 · KPS
Hermes Medical Solutions AB
Radiology · 93d
Cleared Feb 14, 2020
Vitrea Software Package
K192923 · LLZ
Canon Medical Systems Corporation
Radiology · 121d
Cleared Feb 14, 2020
ASCEND Image Viewer
K192372 · LLZ
Ascend Hit
Radiology · 168d
Cleared Feb 14, 2020
CardIQ Flow
K192277 · KPS
GE Medical Systems SCS
Radiology · 176d
Cleared Feb 13, 2020
Infinitt RT PACS
K193498 · LLZ
Infinitt Healthcare Co., Ltd.
Radiology · 58d
Cleared Feb 13, 2020
Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging System
K192828 · JAK
Canon Medical Systems Corporation
Radiology · 134d
Cleared Feb 12, 2020
Biograph Horizon
K193178 · KPS
Siemens Medical Solution USA, Inc.
Radiology · 86d
Cleared Feb 12, 2020
Leltek Ultrasound Imaging System
K191235 · IYN
Leltek, Inc.
Radiology · 280d
Cleared Feb 11, 2020
EzRay Air Portable (Model: VEX-P300)
K200182 · EHD
VATECH Co., Ltd.
Radiology · 18d
Cleared Feb 11, 2020
Acteon Imaging Suite
K192165 · LLZ
De Gotzen S.R.L.
Radiology · 186d
Cleared Feb 10, 2020
Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy...
K192377 · IYE
Varian Medical Systems, Inc.
Radiology · 164d
Cleared Feb 07, 2020
Paragon XHD Diagnostic Ultrasound System
K191347 · IYN
Shenzhen Wisonic Medical Technology...
Radiology · 263d
Not Cleared Feb 07, 2020
Caption Guidance
DEN190040 · QJU
Bay Labs, Inc.
Radiology · 164d
Cleared Feb 06, 2020
Lucy Point-of-Care Magnetic Resonance Imaging Device
K192002 · LNH
Hyperfine Research, Inc.
Radiology · 195d
Cleared Feb 04, 2020
Akesis Galaxy RTx
K200050 · IWB
Akesis, Inc.
Radiology · 25d
Cleared Feb 04, 2020
Motion Correction System
K193324 · LNH
Kineticor, Inc.
Radiology · 64d
Cleared Jan 31, 2020
HAD1717MC
K200018 · MQB
H&Abyz
Radiology · 28d
Cleared Jan 31, 2020
ACUSON Sequoia Diagnostic Ultrasound System
K193257 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 66d
Cleared Jan 31, 2020
syngo.MR Applications
K192462 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 144d
Cleared Jan 31, 2020
1.5T Endorectal Coil, 3.0T Endorectal Coil, ER Coil Support
K191539 · MOS
Rapid Biomedical GmbH
Radiology · 235d
Cleared Jan 28, 2020
MRH ALFA Radiographic System, MRH II Radiographic System, MRH IIE...
K193637 · KPR
Compania Mexicana DE Radiologia Cgr,...
Radiology · 32d
Cleared Jan 28, 2020
Terason uSmart3200T Ultrasound System
K193510 · IYN
Teratech Corporation
Radiology · 41d
Cleared Jan 26, 2020
THD Procto Software System
K193512 · IYO
Thd Spa
Radiology · 39d