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
2137–2160 of 15,695
Search insights Median review: 81d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jan 20, 2022
syngo.CT Extended Functionality
K214019 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 29d
Cleared Jan 20, 2022
SIGNA PET/MR
K213709 · OUO
Ge Medical Systems, LLC
Radiology · 57d
Cleared Jan 20, 2022
SIGNA Hero
K213668 · LNH
Ge Healthcare (Ge Medical Systems, LLC)
Radiology · 59d
Cleared Jan 19, 2022
3D Bolus Software Application, 3D Brachy Software Application,...
K213438 · MUJ
Adaptiiv
Radiology · 89d
Cleared Jan 19, 2022
Follicle Clarity
K212012 · QIH
Cycle Clarity
Radiology · 205d
Cleared Jan 19, 2022
Caption Interpretation Automated Ejection Fraction Software
K210747 · QIH
Caption Health
Radiology · 313d
Cleared Jan 16, 2022
SIGNA Prime
K211980 · LNH
Ge Healthcare (Tianjin) Company Limited
Radiology · 205d
Cleared Jan 14, 2022
Respiratory Gating for Scanners v2.0
K213927 · JAK
Varian Medical Systems, Inc.
Radiology · 29d
Cleared Jan 14, 2022
Quantib ND
K213737 · LLZ
Quantib B.V.
Radiology · 46d
Cleared Jan 14, 2022
Eclipse II with Smart Noise Cancellation
K213307 · MQB
Carestream Health, Inc.
Radiology · 102d
Cleared Jan 14, 2022
Precise Image
K210760 · JAK
Philips Medical Systems Nederland B.V.
Radiology · 305d
Cleared Jan 13, 2022
Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 Expert
K213642 · IYN
Ge Healthcare
Radiology · 56d
Cleared Jan 12, 2022
Straight Arm DDR
K214012 · KPR
Konica Minolta Healthcare Americas, Inc.
Radiology · 21d
Cleared Jan 12, 2022
UNiD Spine Analyzer
K212005 · LLZ
Medicrea International, Inc.
Radiology · 198d
Cleared Jan 11, 2022
Esteya
K213942 · JAD
Nucletron B.V.
Radiology · 25d
Cleared Jan 11, 2022
ES1 System
K213102 · IYN
E-Scopics
Radiology · 109d
Cleared Jan 07, 2022
AIBOLIT 3D+
K211443 · LLZ
Aibolit Technologies, LLC
Radiology · 242d
Cleared Jan 06, 2022
TOMTEC-ARENA
K213544 · QIH
Tomtec Imaging Systems GmbH
Radiology · 59d
Cleared Jan 06, 2022
Gold Anchor
K213053 · IYE
Naslund Medical AB
Radiology · 106d
Cleared Jan 03, 2022
VUZE System
K210830 · LLZ
Vuze Medical , Ltd.
Radiology · 290d
Cleared Dec 30, 2021
eco-x Series (eco-x, eco-x-s)
K211159 · OAS
Hdx Will Corp.
Radiology · 255d
Cleared Dec 29, 2021
LiverSmart
K213776 · PCS
Resonance Health Analysis Services...
Radiology · 27d
Cleared Dec 27, 2021
Sonosite PX Ultrasound System
K213763 · IYN
FUJIFILM Sonosite, Inc.
Radiology · 26d
Cleared Dec 23, 2021
dS FootAnkle 16Ch Coils for 1.5T and 3.0T, dS HiRes HandWrist 16Ch Coils for...
K213766 · MOS
Invivo Corporation
Radiology · 22d