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
6985–7008 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Aug 15, 2008
GE LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM, MODELS 5205000, 5205000-2
K082185 · IYO
Ge Medical Systems Ultrasound and...
Radiology · 14d
Cleared Aug 12, 2008
ECHELON RAPID PV COIL, MODEL MR-PVC-150, ECHELON RAPID FOOT COIL, MODEL...
K081745 · MOS
Hitachi Medical Systems America, Inc.
Radiology · 54d
Cleared Aug 12, 2008
APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA - 790A VERSION 3.0
K082119 · IYN
Toshiba America Medical Systems, In.C
Radiology · 15d
Cleared Aug 07, 2008
ATLAS-BASED AUTOSEGMENTATION
K080799 · LHN
Computerized Medical Systems, Inc.
Radiology · 139d
Cleared Aug 07, 2008
MODIFICATION TO AUTOMATED BREAST ULTRASOUND SYSTEM, MODEL ABUS
K080930 · IYO
U-System, Inc.
Radiology · 127d
Cleared Aug 06, 2008
RFVISION, MODEL 9.9D
K080847 · OWB
Almana Medical Imaging
Radiology · 133d
Cleared Aug 06, 2008
SONIX MDP ULTRASOUND SCANNER
K080935 · IYN
Ultrasonix Medical Corporation
Radiology · 126d
Cleared Aug 06, 2008
EDGE PACS
K081752 · LLZ
Ashva Technologies, Pvt., Ltd.
Radiology · 47d
Cleared Aug 06, 2008
GE VIVID E9 ULTRASOUND
K081921 · IYN
General Electric Co.
Radiology · 30d
Cleared Aug 06, 2008
ALLTECH ECHOSTAR 1.5 T MR SYSTEM
K082100 · LNH
Alltech Medical Systems America, Inc.
Radiology · 12d
Cleared Aug 04, 2008
MODIFICATION TO ONEDOSE PATIENT DOSIMETRY SYSTEM
K081859 · IYE
Sicel Technologies, Inc.
Radiology · 34d
Cleared Aug 01, 2008
FIATLUX VISUALIZE
K082041 · LLZ
Fiatlux Imaging, Inc.
Radiology · 14d
Cleared Jul 30, 2008
THD SLIDE
K081429 · JAF
Thd Spa
Radiology · 70d
Cleared Jul 30, 2008
CARESTREAM DR LONG LENGTH IMAGING SYSTEM FOR DR 7500 SYSTEM
K081836 · KPR
Carestream Health, Inc.
Radiology · 30d
Cleared Jul 29, 2008
FLEXIPLAN BRACHYTHERAPY TREATMENT PLANNING SYSTEM
K081112 · MUJ
Isodose Control B.V.
Radiology · 102d
Cleared Jul 29, 2008
MAMMO WORKSTATION
K081630 · LLZ
Image Diagnost International GmbH
Radiology · 48d
Cleared Jul 29, 2008
RSVP PHANTOM PELVIS, MODEL TLP260
K081760 · IYE
The Phantom Laboratory, Inc.
Radiology · 39d
Cleared Jul 28, 2008
IMPAX MA3000 DIAGNOSTIC PACS WORKSTATION
K081976 · LLZ
Agfa Healthcare Corporation
Radiology · 17d
Cleared Jul 25, 2008
AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX2008 WORKSTATIONS
K081963 · MQB
Agfa Healthcare Corporation
Radiology · 15d
Cleared Jul 22, 2008
SAVI APPLICATOR KIT
K081677 · JAQ
Cianna Medical, Inc.
Radiology · 35d
Cleared Jul 22, 2008
GE SIGNA MR ONCOLOGY PACKAGE
K081916 · LNH
Ge Medical Systems, LLC
Radiology · 15d
Cleared Jul 21, 2008
BELLYSTEP, HEADSTEP, BREASTSTEP, PROSTEP, WINGSTEP AND ICAST
K081218 · IYE
It-V Medizintechnik, GmbH
Radiology · 82d
Cleared Jul 18, 2008
SIMPLANT ORTHO
K081402 · LLZ
Materialise Dental NV
Radiology · 60d
Cleared Jul 18, 2008
STEALTHVIZ ADVANCED PLANNING APPLICATION WITH STEALTHDTI PACKAGE
K081512 · LLZ
Medtronic Navigation, Inc.
Radiology · 49d