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 × Cleared only ×
15,570 results
385–408 of 15,570
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
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
Cleared Oct 01, 2025
Shear Wave Quantificational Ultrasound Diagnostic System...
K250026 · IYN
Wuxi Hisky Medical Technologies Co.,...
Radiology · 268d
Cleared Sep 30, 2025
Astrasono A3Pro Bladder Scanner (A3Pro)
K250331 · IYO
Astrasono Technology Co., Ltd.
Radiology · 237d
Cleared Sep 29, 2025
SMART PCFD
K250023 · QIH
Disior, Ltd.
Radiology · 269d
Cleared Sep 26, 2025
Ligence Heart
K252105 · QIH
Ligence Uab
Radiology · 85d
Cleared Sep 26, 2025
Self-Propelled CT Scan Base Kit, CGBA-035A
K251645 · JAK
Canon Medical Systems Corporation
Radiology · 120d
Cleared Sep 26, 2025
Planmed XFI
K250318 · SFV
Planmed OY
Radiology · 234d
Cleared Sep 25, 2025
uMR 680
K252371 · LNH
Shanghai United Imaging Healthcare...
Radiology · 57d
Cleared Sep 25, 2025
Brain WMH
K251527 · QIH
Quantib B.V.
Radiology · 129d
Cleared Sep 24, 2025
Digital X-Ray DentiMax Pro Imaging System
K251206 · MUH
Dentimax, Inc.
Radiology · 159d
Cleared Sep 24, 2025
uWS-Angio Pro
K250045 · LLZ
Shanghai United Imaging Healthcare...
Radiology · 257d