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 ×
15,695 results
1729–1752 of 15,695
Search insights Median review: 81d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jan 11, 2023
RadianceTx Radionuclide Brachytherapy Source
K223465 · KXK
Radiance Therapeutics, Inc.
Radiology · 55d
Cleared Jan 11, 2023
Transducer Probe Cover
K221278 · ITX
Hony Medical Co., Ltd.
Radiology · 253d
Cleared Jan 09, 2023
21HQ513D
K223789 · PGY
Lg Electronics.Inc
Radiology · 21d
Cleared Jan 09, 2023
Vitrea Software Package, VSTP-002A
K223336 · LLZ
Canon Medical Systems Corporation
Radiology · 69d
Cleared Jan 09, 2023
Sunkingdom Ophthalmic Ultrasound Examination Instrument SK-3000A, SK-3000B,...
K222787 · IYO
Chongqing Sunkingdom Medical...
Radiology · 116d
Cleared Jan 06, 2023
TECHFIT Diagnostic Models
K222577 · LLZ
Techfit Digital Surgery, Inc.
Radiology · 134d
Cleared Jan 03, 2023
3.0T 16ch AIR AA
K223378 · MOS
Ge Healthcare Coils (Usa Instruments,...
Radiology · 57d
Cleared Dec 30, 2022
X-ray Flat Panel Detectors (EverestView 4343X)
K223687 · MQB
Careray Digital Medical Technology...
Radiology · 21d
Cleared Dec 30, 2022
PeekMed web (v1)
K222767 · LLZ
Peek Health, S.A.
Radiology · 108d
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
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