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 × Cleared only ×
15,676 results
1729–1752 of 15,676
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Dec 30, 2022
aprevo® Digital Workflow
K222195 · LLZ
Carlsmed, Inc.
Radiology · 161d
Cleared Dec 30, 2022
Cyware 4H and Cysart 4H
K221796 · LLZ
Abys Medical
Radiology · 192d
Cleared Dec 28, 2022
nView s1 with nav option
K221344 · OWB
Nview Medical
Radiology · 233d
Cleared Dec 23, 2022
MR 5300 and MR 7700 R11 MR Systems
K223442 · LNH
Philips Medical Systems Nederlands B.V.
Radiology · 39d
Cleared Dec 23, 2022
Xenoview VDP
K223071 · LLZ
Polarean, Inc.
Radiology · 84d
Cleared Dec 23, 2022
AVIEW
K214036 · QIH
Coreline Soft Co., Ltd.
Radiology · 365d
Cleared Dec 23, 2022
XENOVIEW 3.0T Chest Coil
K212239 · MOS
Polarean, Inc.
Radiology · 522d
Cleared Dec 22, 2022
Biograph Vision Quadra PET/CT System
K223547 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 27d
Cleared Dec 22, 2022
Philips CT 3500
K223311 · JAK
Philips Healthcare (Suzhou) Co., Ltd.
Radiology · 55d
Cleared Dec 21, 2022
8MP Color LCD Monitor CL-R813
K222864 · PGY
Jvckenwood Corporation
Radiology · 90d
Cleared Dec 21, 2022
VINNO 6PRO, VINNO 6EXP, VINNO 5PRO, VINNO 5EXP, VINNO 3, VINNO 3PRO, VINNO 3EXP
K221911 · IYN
Vinno Technology (Suzhou) Co.,Ltd
Radiology · 174d
Cleared Dec 20, 2022
AirRay
K222896 · IZL
Poskom Co., Ltd.
Radiology · 88d
Cleared Dec 16, 2022
BrainInsight
K223268 · QIH
Hyperfine, Inc.
Radiology · 53d
Cleared Dec 16, 2022
Saige-Density
K222275 · QIH
DeepHealth, Inc.
Radiology · 140d
Cleared Dec 16, 2022
Overjet Calculus Assist
K220928 · MYN
Overjet, Inc.
Radiology · 260d
Cleared Dec 15, 2022
Small Field Applicator
K220883 · LHN
Hitachi, Ltd. Radiation Oncology...
Radiology · 265d
Cleared Dec 09, 2022
3D-SHAPER
K220822 · KGI
3D-Shaper Medical S.L
Radiology · 263d
Cleared Dec 08, 2022
InkSpace Imaging Body Array
K223487 · MOS
Inkspace Imaging, Inc.
Radiology · 17d
Cleared Dec 08, 2022
8ch Wrist Coil
K223239 · MOS
Shenzhen RF Tech Co., Ltd.
Radiology · 49d
Cleared Dec 07, 2022
Cios Select (VA21) Flat Panel
K223410 · OWB
Siemens Medical Solutions USA, Inc.
Radiology · 28d
Cleared Dec 07, 2022
Ultrasound System 2300
K222441 · IYN
Bk Medical Aps
Radiology · 117d
Cleared Dec 06, 2022
Cios Select (VA21) Image Intensifier
K223409 · OWB
Siemens Medical Solutions USA, Inc.
Radiology · 27d
Cleared Dec 06, 2022
Swoop Portable MR Imaging System
K223247 · LNH
Hyperfine, Inc.
Radiology · 46d
Cleared Dec 06, 2022
MedDream
K222320 · LLZ
Softneta Uab
Radiology · 126d