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
7513–7536 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jan 24, 2007
TOPACS
K063294 · LLZ
Radiological Specialists, Inc.
Radiology · 84d
Cleared Jan 24, 2007
INTELEPACS
K070080 · LLZ
Intelerad Medical Systems, Inc.
Radiology · 15d
Cleared Jan 22, 2007
MEDICAL IMAGE MANAGEMENT DEVICES FOR VISION TOOLS
K063439 · LLZ
Mtd, Inc.
Radiology · 70d
Cleared Jan 22, 2007
COR ANALYZER 1, VERSION 1.4
K063548 · LLZ
Rcadia Medical Imaging , Ltd.
Radiology · 59d
Cleared Jan 17, 2007
NORDIC IMAGE CONTROL AND EVALUATION (NICE) SOFTWARE, VERSION 2.1
K063539 · LLZ
Nordicicemedical AS
Radiology · 54d
Cleared Jan 12, 2007
SPY IMAGING SYSTEM
K063345 · IZI
Novadaq Technologies, Inc.
Radiology · 67d
Cleared Jan 12, 2007
SYNGO MI APPLICATIONS 2007A
K063826 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 17d
Cleared Jan 11, 2007
PORTABLE X-RAY SYSTEM, MODEL PORT-X II
K063121 · EHD
Genoray Co., Ltd.
Radiology · 91d
Cleared Jan 09, 2007
SRT100 SUPERFICIAL RADIATION THERAPY SYSTEM
K063456 · JAD
Topex, Inc.
Radiology · 55d
Cleared Jan 05, 2007
AYCAN WORKSTATION OSIRIX
K063470 · LLZ
Aycan Digitalsysteme GmbH
Radiology · 50d
Cleared Jan 05, 2007
SYNGO CIRCULATION SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY
K063762 · JAK
Siemens AG Medical Solutions
Radiology · 16d
Cleared Jan 05, 2007
PHILIPS XD-S DIRECT RADIOGRAPHY WORKSTATION/PACKAGE
K063781 · LLZ
Philips Medical Systems North America...
Radiology · 15d
Cleared Jan 05, 2007
ACUSON ANTARES DIAGNOSTIC ULTRASOUND SYSTEM
K063803 · IYN
Siemens Medical Solutions USA, Inc.,...
Radiology · 14d
Cleared Jan 04, 2007
ACHIEVA, INTERA AND PANORAMA 1.0T, RELEASE 2.5
K063559 · LNH
Philips Medical Systems
Radiology · 38d
Cleared Jan 04, 2007
ACUSON P10 DIAGNOSTIC ULTRASOUND SYSTEM
K063761 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 15d
Cleared Dec 29, 2006
NIO FUSION 4MP
K062905 · LLZ
Barcoview
Radiology · 93d
Cleared Dec 28, 2006
COLLIMATOR, MODEL M-38
K062788 · KPW
Umi International
Radiology · 101d
Cleared Dec 26, 2006
CT EXPRES III CONTRAST MEDIA DELIVERY SYSTEM
K062265 · IZQ
Swiss Medical Care S.A.
Radiology · 144d
Cleared Dec 26, 2006
AMX4-50 AND AMX4-31 MOBILE DIGITAL DIAGNOSTIC RADIOGRAPHIC SYSTEMS
K063262 · IZL
Virtual Imaging
Radiology · 57d
Cleared Dec 26, 2006
HDR CT COMPATIBLE SPLIT RING APPLICATOR
K063382 · JAQ
Mick Radio-Nuclear Instruments, Inc.
Radiology · 48d
Cleared Dec 26, 2006
CRANEX NOVUS
K063459 · MUH
Soredex Palodex Group OY
Radiology · 41d
Cleared Dec 26, 2006
CENTRICITY RADIOLOGY RA600, CARDIOLOGY CA1000 AND DIGITAL HARDCOPY
K063628 · LLZ
Ge Healthcare Integrated IT Solutions
Radiology · 20d
Cleared Dec 22, 2006
CT COMPATIBLE F/S/D APPLICATORS
K063381 · JAQ
Mick Radio-Nuclear Instruments, Inc.
Radiology · 44d
Cleared Dec 21, 2006
INTEGRA RADIONICS IMAGEFUSION 3
K063230 · MUJ
Integra Radionics, Inc.
Radiology · 57d