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
8953–8976 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Dec 11, 2002
GE PHOTON ENERGY RECOVERY (PER) OPTION
K023932 · KPS
Ge Medical Systems F.I. Haifa
Radiology · 15d
Cleared Dec 04, 2002
I-PLANT MODEL 3500 (125IODINE BRACHYTHERAPY SEEDS)-STERILE
K023242 · KXK
Implant Sciences Corp.
Radiology · 65d
Cleared Dec 02, 2002
MODEL AMI1200 C-ARM
K022911 · JAA
Integrity Practice Management, Inc.
Radiology · 90d
Cleared Nov 26, 2002
INNOVA 4100
K023178 · OWB
Ge Medical Systems, Inc.
Radiology · 64d
Cleared Nov 26, 2002
MY BREAST FRIEND, BREAST SELF-EXAM PAD
K023390 · IXH
Mbf Sales, LLC
Radiology · 48d
Cleared Nov 25, 2002
ECAT PET/CT
K023768 · KPS
Cti Pet Systems, Inc.
Radiology · 13d
Cleared Nov 22, 2002
PHILIPS INTEGRIS ALLURA FLAT DETECTOR RELEASE 1.0
K022899 · JAA
Philips Medical Systems North America...
Radiology · 80d
Cleared Nov 22, 2002
AMICAS LIGHT BEAM WORKSTATION, MODEL 1.0
K022970 · LLZ
Amicas, Inc.
Radiology · 77d
Cleared Nov 22, 2002
CEDARS-SINAI MOTION CORRECTION (MOCO) SOFTWARE, MODEL 111005
K023110 · KPS
Digirad Corp.
Radiology · 64d
Cleared Nov 22, 2002
BLOCKING TRAY
K023636 · IYE
Southeastern Radiation Products, Inc.
Radiology · 23d
Cleared Nov 22, 2002
SOMATOM EMOTION 6 CT SYSTEMS
K023687 · JAK
Siemens Medical Systems, Inc.
Radiology · 21d
Cleared Nov 22, 2002
CANNON DIGITAL RADIOGRAPHY MODEL CXDI-40G
K023750 · MQB
Canon USA, Inc.
Radiology · 14d
Cleared Nov 22, 2002
CT CARDIAC FUNCTION ANALYSIS SOFTWARE, MODELS CSCF-001A AND CSCF-001B
K023760 · JAK
Toshiba America Medical Systems, In.C
Radiology · 14d
Cleared Nov 22, 2002
KINETDX PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
K023772 · LLZ
Acuson Corp.
Radiology · 10d
Cleared Nov 21, 2002
ATLANTIS PV IMAGING CATHETER, MODEL 36456
K022860 · ITX
Boston Scientific, Target
Radiology · 85d
Cleared Nov 20, 2002
IMAGECHECKER-CT WORKSTATION
K023003 · LLZ
R2 Technology, Inc.
Radiology · 72d
Cleared Nov 20, 2002
SONOREAL 3D
K023473 · IYO
Bio Medi Com
Radiology · 35d
Cleared Nov 20, 2002
6 CHANNEL BODY COIL
K023571 · MOS
Siemens Medical Systems, Inc.
Radiology · 27d
Cleared Nov 20, 2002
SONOLINE ANTARES ULTRASOUND SYSTEM
K023720 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 15d
Cleared Nov 18, 2002
GORE 3.0T TORSO ARRAY
K023679 · MOS
W.L. Gore & Associates, Inc.
Radiology · 17d
Cleared Nov 14, 2002
DOREX SPECTRUM 9000MB THERMOGRAPHY SYSTEM
K023434 · LHQ
Dorex, Inc.
Radiology · 30d
Cleared Nov 13, 2002
UNIVERSAL SYSTEM, MODEL QV-800
K023008 · KPR
Quantum Medical Imaging, LLC
Radiology · 65d
Cleared Nov 12, 2002
KLARITY
K022708 · IYE
Larson Products, Inc.
Radiology · 90d
Cleared Nov 08, 2002
HOLOGIC QDR X-RAY BONE DENSITOMETER, MODELS 1000, 2000, 4500, DELPHI, DISCOVERY
K023398 · KGI
Hologic, Inc.
Radiology · 30d