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
9433–9456 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared May 23, 2001
ALOKA SSD-5500 WITH KI AND A-SMA
K011457 · IYN
Aloka Co., Ltd.
Radiology · 12d
Cleared May 22, 2001
VHF ULTRASONIC ARC-SCAN SYSTEM
K003890 · IYO
Ultralink, LLC
Radiology · 155d
Cleared May 21, 2001
CARDIAC VIEW, MODEL 2001
K010513 · MOS
Magna-Lab, Inc.
Radiology · 89d
Cleared May 21, 2001
CDMX
K010915 · MUH
Camsight Co., Inc.
Radiology · 55d
Cleared May 18, 2001
GE LOGIQ 9, MODEL 2188900-X
K011188 · IYN
GE Medical Systems
Radiology · 30d
Cleared May 17, 2001
RADCALC, MODEL V.4.0
K010464 · IYE
Lifeline Software, Inc.
Radiology · 90d
Cleared May 16, 2001
MODIFICATION TO FLOW 7000 PERIPHERAL VASCULAR COIL
K010730 · MOS
Usa Instruments, Inc.
Radiology · 65d
Cleared May 16, 2001
E-Z EM PERCUPUMP 2001 CT INJECTOR
K011160 · JAK
E-Z-Em, Inc.
Radiology · 30d
Cleared May 15, 2001
OLYMPUS GF UC140P-AL5 ULTRASONIC ENDOSCOPE WITH ALOKA SSD-5500 ULTRASOUND SYSTEM
K011314 · ITX
Aloka Co., Ltd.
Radiology · 15d
Cleared May 15, 2001
SSD 5500 WITH OLYMPUS GF TYPE UC140P-AL5
K011315 · IYN
Aloka Co., Ltd.
Radiology · 15d
Cleared May 08, 2001
PATIENT DOSE VERIFICATION SYSTEM, MODEL TN-RD-50
K010472 · IYE
Thomson & Nielsen Electronics, Ltd.
Radiology · 77d
Cleared May 08, 2001
BLOOD OXYGENATION LEVEL DEPENDENT (BOLD) OPTION
K010691 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 61d
Cleared May 08, 2001
AQUARIUS WORKSTATION
K011142 · LLZ
Terarecon,Inc.
Radiology · 25d
Cleared May 07, 2001
SIMPLICT
K010813 · JAK
Neorad AS
Radiology · 49d
Cleared May 04, 2001
TETRAD TC-C3-ACP
K002193 · ITX
Tetrad Corp.
Radiology · 288d
Cleared May 04, 2001
IVD (IN VIVO DOSIMETER), MODEL 1131
K010449 · IYE
Sun Nuclear Corp.
Radiology · 78d
Cleared May 04, 2001
HDI 5000 ULTRASOUND SYSTEM WITH ASSISTED BORDER DETECTION (ABD), XRES...
K011224 · IYN
Advanced Technology Laboratories, Inc.
Radiology · 14d
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