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
6553–6576 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jan 12, 2010
LUMOS, MODEL R 72B
K093596 · KPW
Lumos, Inc.
Radiology · 53d
Cleared Jan 11, 2010
EXPLORER 4D TREATMENT PLANNING SYSTEM
K093588 · MUJ
American Radiosurgery, Inc.
Radiology · 53d
Cleared Jan 11, 2010
SDX-SPIRODYNR'X RADIOTHERAPY BREATHING CONTROL
K092479 · IYE
Dyn'R
Radiology · 151d
Cleared Jan 08, 2010
XELERIS 3 PROCESSING AND REVIEW WORKSTATION
K093982 · LLZ
Ge Medical Systems F.I. Haifa
Radiology · 15d
Cleared Jan 08, 2010
PCR ELEVA 1.2
K093355 · LLZ
Philips Medical Systems, Inc.
Radiology · 73d
Cleared Jan 08, 2010
DIGITAL X-RAY IMAGING SYSTEM, MODEL PAX-UNI3D
K090467 · OAS
VATECH Co., Ltd.
Radiology · 319d
Cleared Jan 07, 2010
VIDAR DENTAL FILM DIGITIZER
K093809 · LMA
Vidar Systems Corp.
Radiology · 29d
Cleared Jan 06, 2010
INTRAX FILM PROCESSOR
K093503 · IXW
Velopex International, Inc.
Radiology · 55d
Cleared Jan 06, 2010
3D ASL
K092925 · LNH
Ge Medical Systems, LLC
Radiology · 105d
Cleared Jan 06, 2010
PORTABLE X-RAY SYSTEM, MODEL HAND-RAY
K092772 · EHD
Hanjin Digi-X Co., Ltd.
Radiology · 119d
Cleared Dec 24, 2009
LIFEDOP MODEL 300ABI
K093393 · JAF
Summit Doppler Systems, Inc.
Radiology · 55d
Cleared Dec 24, 2009
PROTON THERAPY MULTILEAF COLLIMATOR
K093250 · LHN
Varian Medical Systems
Radiology · 69d
Cleared Dec 23, 2009
RADIONUCLIDE BRACHYTHERAPY SOURCE
K093663 · KXK
C.R. Bard, Inc.
Radiology · 28d
Cleared Dec 23, 2009
VASCUVIEW TAP ULTRASOUND SYSTEM
K093613 · IYN
Escalon Medical Corp.
Radiology · 30d
Cleared Dec 23, 2009
SIMUPLAN TREATMENT PLANNING SYSTEM
K093391 · MUJ
Simuplan S.L.
Radiology · 54d
Cleared Dec 23, 2009
OTI-SCAN 3000
K092837 · IYO
Opko Instrumentation, Inc.
Radiology · 99d
Cleared Dec 23, 2009
O-SCAN MR SYSTEM
K092469 · LNH
Esaote, S.P.A.
Radiology · 134d
Cleared Dec 23, 2009
ZIEHM SOLO
K092438 · OWB
Ziehm Imaging, Inc.
Radiology · 138d
Cleared Dec 22, 2009
IBA PROTON THERAPY SYSTEM, PROTEUS 235
K092796 · LHN
Ion Beam Applications S.A.
Radiology · 102d
Cleared Dec 17, 2009
GALILEOS IMPLANT, VERSION 1.7
K093090 · LLZ
Sicat GmbH & Co. KG
Radiology · 77d
Cleared Dec 16, 2009
DOSE VOLUME HISTOGRAM (DVH) EVALUATOR
K092928 · MUJ
Diversilabs, LLC
Radiology · 84d
Cleared Dec 15, 2009
ARIA RADIATION ONCOLOGY WITH MIRS
K093527 · IYE
Varian Medical Systems, Inc.
Radiology · 29d
Cleared Dec 15, 2009
TIGRT IVS
K092550 · IYE
Linatech, LLC
Radiology · 118d
Cleared Dec 11, 2009
AEGIS NAVIGATION ANDA EGIS PELVIC APPLICATION
K093672 · LLZ
Sentinelle Medical, Inc.
Radiology · 14d