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
8713–8736 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Sep 17, 2003
APAX PACS SYSTEM
K032760 · LLZ
Tis, Inc.
Radiology · 12d
Cleared Sep 12, 2003
HANDYDOP
K030466 · KNG
Elcat, GmbH
Radiology · 212d
Cleared Sep 12, 2003
3.0T 8-CHANNEL CERVICAL-THORACIC-LUMBAR (CTL) ARRAY COIL
K032538 · MOS
Usa Instruments, Inc.
Radiology · 25d
Cleared Sep 12, 2003
POLESTAR N-20
K032541 · LNH
Odin Medical Technologies , Ltd.
Radiology · 25d
Cleared Sep 12, 2003
3.0T 8 CHANNEL NEUROVASCULAR (NV) ARRAY COIL
K032618 · MOS
Usa Instruments, Inc.
Radiology · 17d
Cleared Sep 11, 2003
LATEX ULTRASONIC PROBE COVER
K022156 · ITX
Pleasure Latex Products Sdn. Bhd.
Radiology · 436d
Cleared Sep 11, 2003
PANTOS, MODELS: PANTOS 16, AND PANTOS DG
K031801 · MUH
Blue X Imaging Srl
Radiology · 92d
Cleared Sep 11, 2003
DOME CX DIGITAL FLAT-PANEL DISPLAY SYSTEM MODEL, C3 COLOR AND C3 GRAY
K032638 · LLZ
Planar Systems, Inc.
Radiology · 15d
Cleared Sep 11, 2003
FULL FIELD BREAST IMAGING (FFBU) DIAGNOSTIC ULTRASOUND SYSTEM
K032640 · IYO
U-Systems, Inc.
Radiology · 15d
Cleared Sep 10, 2003
INTERA-SENSATION FAMILY
K031815 · LNH
Philips Medical Systems
Radiology · 90d
Cleared Sep 10, 2003
SIREMOBIL ISO-C 3D
K032280 · IZL
Siemens AG
Radiology · 48d
Cleared Sep 05, 2003
ONCOR AVANT-GARDE WITH COHERENCE WORKSPACES
K031764 · IYE
Siemens Medical Solutions USA, Inc.
Radiology · 88d
Cleared Sep 05, 2003
ONE DIMENSIONAL WATER PHANTOM, WP 1D
K032594 · IYE
Wellhofer Dosimetrie
Radiology · 14d
Cleared Sep 03, 2003
CYBERKNIFE SYSTEM FOR STEROTACTIC RADIOSURGERY/RADIOTHERAPY
K032345 · MUJ
Accuray, Inc.
Radiology · 35d
Cleared Sep 02, 2003
51CM(20.1INCH) TFT MONOCHROME LCD MONITOR, MU5111BW
K032020 · LLZ
Iiyama Corporation
Radiology · 64d
Cleared Sep 02, 2003
DIGITAL IMAGER
K032022 · LMA
Pyramid Medical, Inc.
Radiology · 64d
Cleared Sep 02, 2003
ACCUFIX RADIOLUCENT PELVIS AND BELLY BOARDS, ACCUFIX CANTILEVER HEAD BOARD...
K032156 · IYE
Wfr/Aquaplast Corp.
Radiology · 50d
Cleared Aug 29, 2003
CAL/RAD MARK VI/VDC-505 DOSE CALIBRATOR, MODEL 34-165
K030066 · KPT
Nuclear Associates
Radiology · 234d
Cleared Aug 29, 2003
OMNIPRO I'MRT
K031634 · IYE
Wellhofer Dosimetrie
Radiology · 94d
Cleared Aug 29, 2003
IMSURE
K031975 · IYE
Prodigm, Inc.
Radiology · 64d
Cleared Aug 27, 2003
LCD MONITOR, RADIFORCE G11, G31, G51
K032026 · LLZ
Eizo Nanao Corporation
Radiology · 58d
Cleared Aug 25, 2003
MILLENNIUM III 4 CHANNEL NEUROVASCULAR COIL
K032415 · MOS
Usa Instruments, Inc.
Radiology · 20d
Cleared Aug 25, 2003
3.0T 4-CHANNEL CERVICO-THORACIC-LUMBAR (CTL) ARRAY COIL
K032474 · MOS
Usa Instruments, Inc.
Radiology · 13d
Cleared Aug 25, 2003
MODIFICARION TO WACKERS-LIU CQ SOFTWARE
K032500 · KPS
Eclipse Systems, Inc.
Radiology · 12d