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
9793–9816 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Mar 27, 2000
MFCD 118
K000291 · LLZ
Barco N.V.
Radiology · 56d
Cleared Mar 27, 2000
MFCD 120
K000294 · LLZ
Barco N.V.
Radiology · 56d
Cleared Mar 27, 2000
VENTRICULAR ANALYSIS TOOLKIT OPTION
K000315 · LNH
GE Medical Systems
Radiology · 55d
Cleared Mar 27, 2000
MLC FIT
K991133 · IYE
Impac Medical Systems, Inc.
Radiology · 360d
Cleared Mar 27, 2000
SONOGRAPHIC PLANNING OF ONCOLOGY TREATMENTS (SPOT), MODEL V.. 1.0
K992303 · MUJ
Nucletron Corp.
Radiology · 263d
Cleared Mar 27, 2000
MCA-601, C-ARM MOBILE
K993896 · JAA
Medison Radiology Systems, Inc.
Radiology · 132d
Cleared Mar 24, 2000
HDI 1500/SA 8800 ULTRASOUND SYSTEM WITH MULTIPLANE TRANSESOPHAGEAL ULTRASOUND...
K994373 · ITX
Atl Ultrasound, Inc.
Radiology · 88d
Cleared Mar 23, 2000
SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7800 SERIES
K994431 · JAK
Shimadzu Medical Systems
Radiology · 84d
Cleared Mar 22, 2000
M.R. VISION 2000 ULTRA AUDIO VISUAL SYSTEM / COMMANDER X6 SYSTEM
K994351 · LNH
Resonance Technology, Inc.
Radiology · 90d
Cleared Mar 22, 2000
RADIOCAMERAS SYSTEM HEAD/NECK APPLICATION
K994355 · IYE
Surgical Navigation Technologies, Inc.
Radiology · 90d
Cleared Mar 21, 2000
I-PLANT, MODEL 3500
K994317 · KXK
Implant Sciences Corp.
Radiology · 90d
Cleared Mar 17, 2000
EBT ULTRAFAST CT SCANNER SYSTEM
K000359 · JAK
Imatron, Inc.
Radiology · 42d
Cleared Mar 16, 2000
IMAGE X-70 PLUS DENTAL X-RAY UNIT
K000551 · EHD
Medical Device Consultants, Inc.
Radiology · 27d
Cleared Mar 16, 2000
GE DOLPHIN DIAGNOSTIC ULTRASOUND SYSTEM, ULTRASONIC PULSED DOPPLER IMAGING...
K000695 · IYO
Ge Medical Systems, Inc.
Radiology · 15d
Cleared Mar 16, 2000
125-IMPLANT SEEDS, MODEL STM1250
K991881 · KXK
Sourcetech Medical, LLC
Radiology · 288d
Cleared Mar 16, 2000
FONAR 360 DEGREE MAGNETIC RESONANCE IMAGING SCANNER
K994287 · LNH
Fonar Corp.
Radiology · 87d
Cleared Mar 16, 2000
BABY FACE
K994385 · IYO
Sonora Medical Systems
Radiology · 79d
Cleared Mar 14, 2000
BARCOMED 5MP1H
K000014 · LLZ
Barco N.V.
Radiology · 71d
Cleared Mar 14, 2000
BARCOMED 5MP2
K000016 · LLZ
Barco N.V.
Radiology · 71d
Cleared Mar 14, 2000
POCKET ULTRASONIC OPHTHALMIC PACHYMETER, BIOMETRY TRANSDUCER FOR POCKET
K000554 · IYO
Quantel Medical
Radiology · 25d
Cleared Mar 14, 2000
MODEL 445SI-64E QUADRATURE WRIST COIL
K000589 · MOS
Igc-Medical Advances, Inc.
Radiology · 21d
Cleared Mar 14, 2000
PROSTEC 125I BRACHYTHERAPY SEEDS
K993280 · KXK
Prostec, LLC
Radiology · 166d
Cleared Mar 14, 2000
ORTHORALIX 9200, ORTHORALIX 9200 PLUS, ORTHORALIX 9200 CEPH, ORTHORALIX 9200...
K994285 · EHD
Dentsply Intl.
Radiology · 85d
Cleared Mar 14, 2000
SURGI-VISION ESOPHAGEAL STYLET COIL
K994436 · MOS
Surgi-Vision, Inc.
Radiology · 75d