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
481–504 of 15,676
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Oct 24, 2025
Cocoon Solo (DX-7020s)
K250687 · MUH
Dexcowin Global, Inc.
Radiology · 232d
Cleared Oct 23, 2025
TeraRecon Cardiovascular.Calcification.CT
K250288 · QIH
Terarecon,Inc.
Radiology · 265d
Cleared Oct 22, 2025
ANDI 2.0
K252298 · QIH
Imeka Solutions, Inc.
Radiology · 91d
Cleared Oct 22, 2025
Sirona Advanced Imaging Suite
K251030 · LLZ
Sirona Medical
Radiology · 202d
Cleared Oct 20, 2025
InkSpace Imaging Small Body Array (SBA12PH30x)
K253182 · MOS
Inkspace Imaging, Inc.
Radiology · 24d
Cleared Oct 20, 2025
brAIn™ Shoulder Positioning
K252665 · QIH
Avatar Medical
Radiology · 56d
Cleared Oct 17, 2025
X1-FFR
K251355 · QHA
Spectrawave, Inc.
Radiology · 170d
Cleared Oct 17, 2025
MOSkin Radiation Measurement System
K250911 · IYE
Electrogenics Labs, Ltd.
Radiology · 205d
Cleared Oct 16, 2025
Viewer (5.4)
K252476 · LLZ
Brainlab AG
Radiology · 70d
Cleared Oct 15, 2025
AGFA HealthCare Enterprise Imaging
K252199 · LLZ
Agfa Healthcare N.V.
Radiology · 93d
Cleared Oct 15, 2025
syngo.CT Dual Energy
K251805 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 125d
Cleared Oct 10, 2025
Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging
K251602 · OWB
Canon Medical Systems Corporation
Radiology · 136d
Cleared Oct 09, 2025
Lux HD 2530 detector (Lux HD 2530)
K252911 · MQB
Iray Imaging Technology (Haining)...
Radiology · 27d
Cleared Oct 09, 2025
EPIQ Series Diagnostic Ultrasound System
K251651 · IYN
Philips Ultrasound, LLC
Radiology · 133d
Cleared Oct 08, 2025
ProKnow DS
K251363 · LLZ
Elekta Solutions AB
Radiology · 160d
Cleared Oct 08, 2025
GT300
K250060 · OAS
Genoray Co., Ltd.
Radiology · 271d
Cleared Oct 07, 2025
TrueBeam, TrueBeam STX, Edge and VitalBeam
K252948 · IYE
Varian Medical Systems, Inc.
Radiology · 21d
Cleared Oct 07, 2025
AIAS Cephalon
K252214 · QIH
Metamorphosis GmbH
Radiology · 84d
Cleared Oct 06, 2025
BlineSlide
K252007 · QIH
Deep Breathe, Inc.
Radiology · 101d
Cleared Oct 03, 2025
Bunkerhill MAC
K250662 · JAK
BunkerHill Health
Radiology · 212d
Cleared Oct 03, 2025
HPACS
K250039 · LLZ
Healthhub
Radiology · 268d
Cleared Oct 02, 2025
Philips IntelliSpace Cardiovascular
K251215 · LLZ
Philips Medical Systems Nederland B.V.
Radiology · 167d
Cleared Oct 02, 2025
LungQ 4
K250766 · JAK
Thirona BV
Radiology · 203d
Cleared Oct 01, 2025
PRO-DOSE System
K250083 · NZT
Nu-Rise, SA
Radiology · 261d