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
8305–8328 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Sep 24, 2004
LEONARDO SYNGO CARDIOLOGY WORKSTATION
K042203 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 39d
Cleared Sep 24, 2004
MILLENNIUM III 3T-8-CHANNEL NEUROVASCULAR COIL
K042342 · MOS
Usa Instruments, Inc.
Radiology · 25d
Cleared Sep 22, 2004
MHLX7EC TRANSDUCER
K040213 · ITX
Microhelix, Inc.
Radiology · 236d
Cleared Sep 21, 2004
ULTRASOUND CAPTURE SYSTEM
K042042 · LLZ
Heartlab, Inc.
Radiology · 54d
Cleared Sep 17, 2004
XPLORER 1600
K042041 · MQB
Imaging Dynamics Company Limited
Radiology · 50d
Cleared Sep 17, 2004
ROBOCOUCH PATIENT SUPPORT SYSTEM
K042146 · JAI
Accuray Incorporated
Radiology · 39d
Cleared Sep 17, 2004
SCEPTREP3 PET/CT
K042428 · KPS
Hitachi Medical Systems America, Inc.
Radiology · 9d
Cleared Sep 16, 2004
ERGOSONIX ULTRASOUND SCANNER, MODULO ULTRASOUND SCANNER
K042326 · IYN
Ultrasonix Medical Corporation
Radiology · 20d
Cleared Sep 14, 2004
SOMATOM SPIRIT
K042328 · JAK
Siemens Medical Systems, Inc.
Radiology · 18d
Cleared Sep 09, 2004
PACSPARTNER
K042311 · LLZ
Medical Standard Co., Ltd.
Radiology · 14d
Cleared Sep 09, 2004
INTEGRADWEB MPR/MIP
K042313 · LLZ
Dynamic Imaging, Inc.
Radiology · 14d
Cleared Sep 08, 2004
DISCOVERY ST PET/CT IMAGING SYSTEM WITH AN ALTERNATE DETECTOR OPTION
K042257 · KPS
General Electric Co.
Radiology · 19d
Cleared Sep 08, 2004
LEKSELL GAMMAPLAN 4C WITH MULTIVIEW
K042269 · MUJ
Elekta Instrument AB
Radiology · 16d
Cleared Sep 08, 2004
ISITE PACS
K042292 · LLZ
Stentor, Inc.
Radiology · 15d
Cleared Sep 08, 2004
BRILLIANCE CT, PRIVATE PRACTICE CV CONFIGURATION, CT SCANNER
K042293 · JAK
Philips Medical Systems (Cleveland),...
Radiology · 15d
Cleared Sep 07, 2004
PHOT-X II, MODEL 303
K042260 · EHD
Takara Belmont USA, Inc.
Radiology · 15d
Cleared Sep 03, 2004
ULTRAVISUAL
K042008 · LLZ
Emageon Uv, Inc.
Radiology · 39d
Cleared Sep 02, 2004
TARGETSCAN BIOPSY KIT
K041638 · ITX
Envisioneering, LLC
Radiology · 77d
Cleared Sep 02, 2004
TARGETSCN TRANSRECTAL ULTRASOUND SYSTEM
K041639 · IYO
Envisioneering, LLC
Radiology · 77d
Cleared Sep 01, 2004
TARGETSCAN TRANSRECTAL ULTRASOUND SYSTEM
K041637 · ITX
Envisioneering, LLC
Radiology · 76d
Cleared Sep 01, 2004
SOMATOM RADIATION TREATMENT PLANNING (RTP) PACKAGE
K042229 · JAK
Siemens Medical Solution, Inc. USA
Radiology · 15d
Cleared Aug 30, 2004
EV APAN DIGITAL, MODEL K1VSM2000
K041120 · MUH
Afp Imaging Corp.
Radiology · 123d
Cleared Aug 27, 2004
BARCOVIEW CORONIS 5MP HD MEDICAL FLAT PANEL DISPLAY SYSTEM
K041508 · LLZ
Barco NV Barcoview
Radiology · 81d
Cleared Aug 27, 2004
RADIONICS XKNIFE RT 3 WITH NON STEREOTACTIC MODULE
K041997 · MUJ
Radionics, A Division of Tyco...
Radiology · 32d