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
9433–9456 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jul 03, 2001
SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7800TC
K011141 · JAK
Shimadzu Corp.
Radiology · 81d
Cleared Jun 29, 2001
PROMAX, PANORAMIC X-RAY UNIT WITH CEPHALOSTAT
K011619 · EHD
Planmeca Oy
Radiology · 35d
Cleared Jun 27, 2001
CYPRESS SYSTEM
K010950 · IYO
Acuson Corp.
Radiology · 90d
Cleared Jun 27, 2001
CT/MASTER, VERSION 1.0
K011180 · JAK
Columbia Scientific, Inc.
Radiology · 71d
Cleared Jun 26, 2001
SYNGO MULTIMODALITY WORKSTATION
K010938 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 89d
Cleared Jun 25, 2001
BRACHYSEED PD-103 MODELS #PD1
K011119 · KXK
Draximage, Inc.
Radiology · 74d
Cleared Jun 20, 2001
PTW DOSIMETRY DIODE, T60008
K010916 · IYE
Ptw-New York Corp.
Radiology · 85d
Cleared Jun 20, 2001
ZIEHM VISION
K011292 · OWB
Ziehm International, Inc.
Radiology · 51d
Cleared Jun 20, 2001
Q-RAD RADIOGRAPHIC SYSTEM
K011486 · KPR
Quantum Medical Imaging, LLC
Radiology · 36d
Cleared Jun 15, 2001
MX8000 V5.0 CT SYSTEM
K010817 · JAK
Philips Medical Systems (Cleveland),...
Radiology · 88d
Cleared Jun 15, 2001
QUANTITATIVE GATED SPECT (QGS), QUANTITATIVE PERFUSION SPECT (QPS)
K011572 · KPS
Digirad Corp.
Radiology · 25d
Cleared Jun 13, 2001
MODEL I0-3DUIMS 3D ULTRASOUND MANAGEMENT SYSTEM
K011095 · IYO
Iodp SA
Radiology · 64d
Cleared Jun 08, 2001
BREAST-BOARD (MULTIPLE)
K003778 · IYE
Arplay Medical S.A.
Radiology · 183d
Cleared Jun 08, 2001
CARDIAC VIEW, MODEL 2001
K010802 · MOS
Magna-Lab, Inc.
Radiology · 84d
Cleared Jun 08, 2001
ULTRASOUND SCANNER, TYPE 2102
K011417 · IYO
B & K Medical A/S
Radiology · 30d
Cleared Jun 08, 2001
CARDIOCAM MODEL 9CSY0799
K011611 · KPS
Danish Diagnostic Development A/S
Radiology · 14d
Cleared Jun 08, 2001
LIFEJET PRINTER 400
K011617 · LMC
Ferrania S.P.A. Stabilimento DI Ferrania
Radiology · 14d
Cleared Jun 08, 2001
EXPEDIO 500D R&F X-RAY SYSTEM
K011624 · JAA
GE Medical Systems
Radiology · 14d
Cleared Jun 07, 2001
XSCAN32 TELERADIOLOGY SOFTWARE
K002911 · LLZ
Radiographic Digital Imaging, Inc.
Radiology · 262d
Cleared Jun 06, 2001
QED DIODE DETECTORS, MODELS 1112-1116
K011466 · LNH
Sun Nuclear Corp.
Radiology · 23d
Cleared Jun 06, 2001
PINNACLE MAGNETIC RESONANCE IMAGING SCANNER
K011485 · LNH
Fonar Corp.
Radiology · 22d
Cleared Jun 05, 2001
HELAX-TMS V 5.1 RADIATION THERAPY TREATMENT PLANNING SYSTEM
K010682 · MUJ
Mds Nordion
Radiology · 90d
Cleared May 30, 2001
BREAST BIOPSY DEVICE/MAGNETOM SYSTEMS
K010773 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 77d
Cleared May 30, 2001
MARK 9000 PHASED ARRAY SHOULDER COIL
K010946 · MOS
Usa Instruments, Inc.
Radiology · 62d