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
9265–9288 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Dec 07, 2001
CYBERMED, INC., V-WORKS
K013878 · LLZ
Cybermed, Inc.
Radiology · 14d
Cleared Dec 06, 2001
ORTHOPHOS DS/DC CEPH, ORTHOPHOS 5/PLUS/CD
K013650 · MUH
Sirona Dental Systems GmbH
Radiology · 30d
Cleared Dec 06, 2001
MODIFICATION TO SIDEXIS DIGITAL RADIOGRAPHY IMAGING SYSTEM
K013659 · MUH
Sirona Dental Systems GmbH
Radiology · 30d
Cleared Dec 05, 2001
FOCAL SIM
K013112 · MUJ
Computerized Medical Systems, Inc.
Radiology · 78d
Cleared Dec 05, 2001
ISITE RADIOLOGY
K013630 · LLZ
Stentor, Inc.
Radiology · 30d
Cleared Dec 05, 2001
GENETRA
K013660 · KXK
Radiomed Corporation
Radiology · 29d
Cleared Dec 04, 2001
CTXA HIP
K002113 · KGI
Mindways Software, Inc.
Radiology · 545d
Cleared Dec 04, 2001
MILLCOMP
K011845 · IYE
Math Resolutions, LLC
Radiology · 175d
Cleared Dec 03, 2001
IMAGYN ISOSLEEVE / ISOSTAR NEEDLE SYSTEM
K010166 · IWJ
Imagyn Medical Technologies, Inc.
Radiology · 319d
Cleared Dec 03, 2001
XPLAN 2.2 WITH THE BODY SYSTEM
K013661 · MUJ
Radionics, A Division of Tyco...
Radiology · 27d
Cleared Dec 03, 2001
TETRAD MODEL TC-EC7-ACP, -L5-, -L7-, -V4-ACP TRANSDUCERS
K013849 · ITX
Tetrad Corp.
Radiology · 13d
Cleared Nov 30, 2001
GIOTTO IMAGE
K012953 · IZH
Medx, Inc.
Radiology · 87d
Cleared Nov 29, 2001
DRYSTAR, MODEL 4500M
K012941 · LMC
Agfa Corp.
Radiology · 90d
Cleared Nov 27, 2001
CARDIOVASCULAR ARRAY
K013810 · MOS
W.L. Gore & Associates, Inc.
Radiology · 12d
Cleared Nov 20, 2001
SIGNA OPENSPEED MAGNETIC RESONANCE SYSTEM
K012875 · LNH
GE Medical Systems
Radiology · 85d
Cleared Nov 20, 2001
HRH-127-ALLEGRA HEAD ARRAY COIL
K013508 · MOS
Mri Devices Corp.
Radiology · 29d
Cleared Nov 20, 2001
HNC-63-INT NEUROVASCULAR ARRAY COIL
K013602 · MOS
Mri Devices Corp.
Radiology · 20d
Cleared Nov 20, 2001
EFILM VIDEO
K013631 · LMA
Efilm Medical, Inc.
Radiology · 15d
Cleared Nov 16, 2001
SONOACE SA-8000 DIAGNOSTIC ULTRASOUND SYSTEM
K013627 · IYN
Medison America, Inc.
Radiology · 11d
Cleared Nov 15, 2001
DIGITAL RADIOGRAPHY SYSTEM, MODEL DFP-8000D
K013608 · OWB
Toshiba America Medical Systems, In.C
Radiology · 15d
Cleared Nov 14, 2001
ADC PEDIATRIC
K012750 · MQB
Agfa Corp.
Radiology · 90d
Cleared Nov 14, 2001
ALTAIR MODEL, DEI SYSTEM (DIFFRACTIVE ENERGY IMAGING SYSTEM)
K013291 · NCS
Advanced Diagnostics, Inc.
Radiology · 43d
Cleared Nov 13, 2001
SCANTAC MEMBRANE OR SCANTAC STRIP
K013170 · ITX
Sonotech, Inc.
Radiology · 50d
Cleared Nov 13, 2001
SSA-770A, APLIO ULTRASOUND SYSTEM
K013633 · IYO
Toshiba America Medical Systems, In.C
Radiology · 8d