FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology ×
15,620 results
9289–9312 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Dec 13, 2001
CRYSTAL 5000 PHASES ARRAY TMJ COIL
K013528 · MOS
Usa Instruments, Inc.
Radiology · 51d
Cleared Dec 11, 2001
INTERA I/T
K013344 · LNH
Philips Medical Systems North America...
Radiology · 63d
Cleared Dec 10, 2001
NURVO 9000 ENDOCAVITARY COILS
K011683 · MOS
Usa Instruments, Inc.
Radiology · 194d
Cleared Dec 07, 2001
NOMOS MOTORIZED CRANE II
K013036 · JAI
Nomos Corp.
Radiology · 88d
Cleared Dec 07, 2001
KIMAX REMOTE VIEWING STATION
K013098 · LLZ
Medical Metrics, Inc.
Radiology · 81d
Cleared Dec 07, 2001
VIATRONIC V3D CALCIUM SCORING
K013146 · JAK
Viatronix, Inc.
Radiology · 78d
Cleared Dec 07, 2001
KODAK DIRECTVIEW TABLETOP CASSETTE
K013686 · IXA
Eastman Kodak Company
Radiology · 30d
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