FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology ×
15,589 results
1633–1656 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
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
Not Cleared Dec 23, 2022
BioXmark
DEN220017 · QUV
Nanovi A/S
Radiology · 294d
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