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
9481–9504 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared May 02, 2001
ECLIPSE 6.5
K010975 · IYE
Varian Medical Systems, Inc.
Radiology · 30d
Cleared Apr 27, 2001
DRYSTAR 4500 PRINTER, MODEL 4500
K010275 · LMC
Agfa Medical Imaging
Radiology · 87d
Cleared Apr 27, 2001
CEDARS-SINAI BPGS AND MOCO
K010509 · KPS
Smv America
Radiology · 65d
Cleared Apr 26, 2001
MEDIFACE PACS
K010259 · LLZ
Mediface Co., Ltd.
Radiology · 87d
Cleared Apr 26, 2001
THERASEED(R) PALLADIUM-103 IMPLANT
K010283 · KXK
Theragenics Corp.
Radiology · 86d
Cleared Apr 26, 2001
CAL/RAD MARK IV-DOSE CALIBRATOR 34-162 VEENSTRA MODEL # VDC-304
K010417 · KPT
Nuclear Assoc., Div. Inovision LP
Radiology · 73d
Cleared Apr 26, 2001
MODIFICATION TO MIRAGE
K010726 · LLZ
Segami Corp., Inc.
Radiology · 45d
Cleared Apr 25, 2001
GLIASITE RADIATION THERAPY SYSTEM (RTS), MODEL 1020,1030,1040,8150,9005
K003206 · KXK
Proxima Therapeutics, Inc.
Radiology · 194d
Cleared Apr 24, 2001
DOSIMETRY CHECK
K010225 · IYE
Math Resolutions, LLC
Radiology · 90d
Cleared Apr 18, 2001
LEAD BLOCKS
K010172 · IXI
Arplay Medical S.A.
Radiology · 90d
Cleared Apr 18, 2001
TRAY ADAPTERS, MULTIPLE
K010174 · IYE
Arplay Medical S.A.
Radiology · 90d
Cleared Apr 17, 2001
FG-36UX, FIBER ULTRASOUND GASTROSCOPE
K010740 · ODG
Pentax Precision Instrument Corp.
Radiology · 35d
Cleared Apr 12, 2001
U04
K010942 · OWB
Siemens Medical Solutions USA, Inc.
Radiology · 14d
Cleared Apr 11, 2001
FIESTA IMAGING OPTION
K002997 · LNH
GE Medical Systems
Radiology · 197d
Cleared Apr 11, 2001
ECHOSEED/IODINE-125 SEEDS, MODEL 6733
K010821 · KXK
Medi-Physics Inc. Dba Nycomed...
Radiology · 23d
Cleared Apr 10, 2001
PLATO SRS STEREOTACTIC RADIOSURGERY PLANNING SYSTEM,MODEL 2.0, PLATO IFS...
K010784 · MUJ
Nucletron Corp.
Radiology · 26d
Cleared Apr 09, 2001
BREAST IMMOBIIZATION AND BIOPSY DEVICE MR-BIOPSY 160
K010570 · LNH
Mri Devices Corp.
Radiology · 42d
Cleared Apr 06, 2001
TERATECH MODEL 8EC4 ENDOCAVITY SMART PROBE
K010883 · ITX
Teratech Corp.
Radiology · 14d
Cleared Apr 05, 2001
EXCELART WITH PIANISSIMO, MODEL MRT-1500/P3
K010129 · LNI
Toshiba America Medical Systems, In.C
Radiology · 79d
Cleared Apr 03, 2001
3.0.T SIGNA VH/I (T/R) BODY IMAGING COIL
K003613 · MOS
GE Medical Systems
Radiology · 132d
Cleared Apr 03, 2001
ULTRASOUND SCANNER TYPE 2102
K003986 · IYN
B & K Medical A/S
Radiology · 98d
Cleared Apr 03, 2001
MODEL 455GE PHASED ARRAY WRIST COIL
K010074 · MOS
Medical Advances, Inc.
Radiology · 84d
Cleared Apr 03, 2001
THINKINGNET
K010271 · LLZ
Thinking Systems Corp.
Radiology · 64d
Cleared Apr 03, 2001
MAMMOGRAPH
K010792 · IZH
Digitec Medical Service Corp.
Radiology · 18d