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.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology × Cleared only ×
15,488 results
10273–10296 of 15,488
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared May 11, 1998
PHILIPS GYROSCAN NT RELEASE 6 SERIES
K980645 · LNH
Philips Medical Systems North...
Radiology · 81d
Cleared May 11, 1998
AIRIS MAGNETIC RESONANCE DIAGNOSTIC DEVICE
K980691 · MOS
Hitachi Medical Systems America, Inc.
Radiology · 77d
Cleared May 11, 1998
LUMISCAN 135 PHOSPHOR PLATE DIGITIZER/LUMISYS 135 ERASER
K980809 · LMA
Lumisys, Inc.
Radiology · 69d
Cleared May 08, 1998
COZUMEL DIAGNOSTIC ULTRASOUND SYSTEM
K981505 · IYO
Sonosite,Inc.
Radiology · 14d
Cleared May 08, 1998
SONOACE 6000/ ULTRAMARK 400
K981510 · IYO
Medison America, Inc.
Radiology · 10d
Cleared May 06, 1998
DIFFUSION PACKAGE / GYROSCAN NT
K973658 · LNH
Philips Medical Systems North...
Radiology · 223d
Cleared May 06, 1998
ECHOTECH 3D FREESCAN
K980308 · IYO
Echotech 3D Imaging Systems GmbH
Radiology · 99d
Cleared May 06, 1998
VSS, VIRTUAL SIMULATION SYSTEM
K980629 · IYE
Nucletron Corp.
Radiology · 77d
Cleared May 06, 1998
VR NETSERVE
K980684 · LMD
I.S.G. Technologies, Inc.
Radiology · 72d
Cleared May 06, 1998
AUTOQUANT QUANTITATIVE PERFUSION SPECT (QPS) & QUANTITATIVE GATED SPECT (QGS)
K980715 · KPS
Adac Laboratories
Radiology · 71d
Cleared May 06, 1998
FACTS MONOBLOCK
K981267 · IZX
Dynarad Corp.
Radiology · 29d
Cleared May 04, 1998
MEDRAD DISPOSABLE MRI KIT W/CHECK VALVE MODELSQK 65V, MEDRAD MRI INTEGRAL T...
K980417 · LNH
Medrad, Inc.
Radiology · 90d
Cleared Apr 30, 1998
CS2000 & CS2000 TOMO
K973834 · IZF
Pausch Corp.
Radiology · 204d
Cleared Apr 30, 1998
MEDRAD ATD-T INTERFACE DEVICE
K974438 · MOS
Medrad, Inc.
Radiology · 157d
Cleared Apr 30, 1998
CP 1000, CURIX HT 330, CLASSIC E.O.S., CURIX HT 530, MAMORAY HT 300, MAMORAY...
K981280 · IXW
Bayer Corp., Agfa Div.
Radiology · 22d
Cleared Apr 24, 1998
IMEX MEDICAL SYSTEMS, INC. IMEXLAB 9000
K973556 · IYN
Imex Medical Systems, Inc.
Radiology · 217d
Cleared Apr 24, 1998
ACCENT 16, ACCENT 22
K980322 · OXO
GE Medical Systems
Radiology · 87d
Cleared Apr 24, 1998
CAPINTEC MODEL 292 ELECTROMETER
K980402 · IYE
Capintec, Inc.
Radiology · 81d
Cleared Apr 24, 1998
SONOLINE ELEGRA DIAGNOSTIC ULTRASOUND SYSTEM WITH SUPERFICIAL MUSCULOSKELETAL...
K980557 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 70d
Cleared Apr 22, 1998
GALAXY INTRAVASCULAR ULTRASOUND SYSTEM, MODEL I5028
K980851 · IYO
Boston Scientific Corp
Radiology · 48d
Cleared Apr 17, 1998
SWARTZ DOPPLER FLOW PROBE AND MONITOR SYSTEM
K964001 · ITX
Med Institute, Inc.
Radiology · 557d
Cleared Apr 17, 1998
VIDAR VXR LS LASER FILM DIGITIZER
K974315 · LMA
Vidar Systems Corp.
Radiology · 151d
Cleared Apr 17, 1998
OLDELFT DIGIDELCA
K980296 · KPR
Oldelft Corp. of America
Radiology · 80d
Cleared Apr 17, 1998
PLANMECA DIXI, DIGITAL INTRAORAL X-RAY IMAGING SYSTEM
K980581 · EHD
Planmeca Oy
Radiology · 59d