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
8977–9000 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Dec 17, 2002
ISOROD PD-103 IMPLANT, MODEL ATI-PD-103
K020683 · KXK
Ati Medical, Inc.
Radiology · 288d
Cleared Dec 16, 2002
MODEL 472GE-128: QUADRATURE LOWER EXTREMITY COIL
K023084 · MOS
Medical Advances, Inc.
Radiology · 90d
Cleared Dec 13, 2002
BARCO MEDIS 2MP1NT MEDICAL DIAGNOSTIC DISPLAY SYSTEM
K022773 · LLZ
Barco N.V.
Radiology · 114d
Cleared Dec 13, 2002
S.O.F.T. PADDLE (SPECIAL OPTIMIZED FULL COMPRESSION TRAY), MODEL SFT-PDLE
K023229 · IZH
American Mammographics, Inc.
Radiology · 77d
Cleared Dec 13, 2002
APEX HRI DIGITAL RADIOGRAPHY SYSTEM
K023292 · MUH
Krugman Technologies, Inc.
Radiology · 72d
Cleared Dec 12, 2002
SONOSITE HAND-CARRIED ULTRASOUND SYSTEM (C2 SERIES)
K023957 · IYN
Sonosite,Inc.
Radiology · 15d
Cleared Dec 11, 2002
HUDSON 2020, 2040, 2060,ULTRASOUND SCANNERS
K022928 · IYO
Hudson Diagnostic Imaging, LLC
Radiology · 98d
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