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.

176,325 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology ×
15,668 results
12313–12336 of 15,668
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jan 15, 1993
SIM/PLANT
K924810 · JAK
Columbia Scientific, Inc.
Radiology · 112d
Cleared Jan 15, 1993
NEW DETECTOR OPTION
K924878 · IYX
Adac Laboratories
Radiology · 136d
Cleared Jan 15, 1993
CATHSCANNER VISIONS MICRORAIL ULTRA IMAG CATH
K924980 · ITX
Endosonics Corp.
Radiology · 106d
Cleared Jan 15, 1993
VORTECH'S AUTOROUTER (AUTOMATIC IMAGE ROUTING)
K925097 · LMD
Vortech Data, Inc.
Radiology · 99d
Cleared Jan 15, 1993
SMT-50XM MAGNETIC RESONANCE IMAGING SYSTEM
K925107 · LNH
Shimadzu Medical Systems
Radiology · 98d
Cleared Jan 15, 1993
GIOTTO PATIENT BED
K925212 · IZH
Gold Coast Imaging, Inc.
Radiology · 91d
Cleared Jan 15, 1993
AX-700LE AUTOMATIC X-RAY FILM PROCESSOR
K925569 · IXW
Alphatek Corp.
Radiology · 73d
Cleared Jan 12, 1993
3DTOF MRA
K923870 · LNH
Resonex, Inc.
Radiology · 162d
Cleared Jan 12, 1993
EQUILIBRIUM RADIONUCLIDE ANGIOCARDIORAPHY ANALYSIS
K925186 · KPS
Strichman Medical Equipment, Inc.
Radiology · 90d
Cleared Jan 04, 1993
EP 3000
K924879 · JAA
Oec-Diasonics, Inc.
Radiology · 98d
Cleared Jan 04, 1993
DPD-510 THERAPEUTIC RADIATION DOSIMETER
K925133 · IWB
Scanditronix, Inc.
Radiology · 83d
Cleared Dec 30, 1992
BRAINSCAN BRACHYTHERAPY MODULE
K920880 · KXK
Brainlab
Radiology · 308d
Cleared Dec 30, 1992
CINENET CARDIAC IMAGE NETWORK
K924708 · IZI
Sony Medical Systems
Radiology · 103d
Cleared Dec 30, 1992
ANCOR
K924719 · IZI
Siemens Medical Solutions USA, Inc.
Radiology · 100d
Cleared Dec 30, 1992
MAG RES DIAG DEVI ACCESS CIR POLAR(CP) SPINE COIL
K924756 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 98d
Cleared Dec 30, 1992
CARDIAC STRESS TABLE, 056-180/UNIV ROLL STRESS ATT
K926082 · IZI
Biodan Medical Systems, Ltd.
Radiology · 29d
Cleared Dec 29, 1992
BRAINSCAN RADIOSURGERY MODULE
K920879 · IYE
Brainlab
Radiology · 307d
Cleared Dec 28, 1992
HFG 350, 650, 1050
K923455 · KPR
Varian Canada, Inc.
Radiology · 167d
Cleared Dec 28, 1992
CSP-A (CEILING SUSPENDED POSITIONER-ANGIO)
K924137 · IZI
Fischer Imaging Corp.
Radiology · 132d
Cleared Dec 28, 1992
PHILIPS MEDIO CP FAMILY
K925105 · IZO
Philips Medical Systems, Inc.
Radiology · 81d
Cleared Dec 28, 1992
LIXI IMAGING SCOPE. MODIFICATION
K925251 · JAA
Lixi, Inc.
Radiology · 73d
Cleared Dec 28, 1992
ACCURAD-200 SYSTEM & ACCURAD-300 PLUS SYSTEM
K925705 · IWY
Denar Corp.
Radiology · 46d
Cleared Dec 28, 1992
PHILIPS SUPER CP FAMILY
K925844 · IZO
Philips Medical Systems, Inc.
Radiology · 40d
Cleared Dec 24, 1992
VECTRA MAGNETIC RESONANCE SYSTEM
K921653 · LNH
General Electric Co.
Radiology · 261d