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
8425–8448 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jun 30, 2004
PRECISION RXI ANALOG X-RAY SYSTEM
K041605 · OWB
General Medical Merate S.P.A
Radiology · 15d
Cleared Jun 29, 2004
IMAGERAYI
K041580 · MUH
Henry Schein, Inc.
Radiology · 15d
Cleared Jun 25, 2004
ONEDOSE PATIENT DOSIMETRY SYSTEM
K040687 · IYE
Sicel Technologies, Inc.
Radiology · 101d
Cleared Jun 25, 2004
MOBILEMOSFET WIRELESS DOSIMETRY SYSTEM, MODEL TN-RD-70-W
K041557 · IYE
Thomson & Nielsen Electronics, Ltd.
Radiology · 15d
Cleared Jun 25, 2004
PINNACLE3 RADIATION THERAPY PLANNING SYSTEM
K041577 · LNH
Adac Laboratories
Radiology · 11d
Cleared Jun 24, 2004
MONOCHROME LCD MONITOR, MODEL RADIFORCE G22
K041597 · LLZ
Eizo Nanao Corporation
Radiology · 30d
Cleared Jun 23, 2004
ACCUSOFT
K040474 · MUJ
Direx Systems Corp.
Radiology · 120d
Cleared Jun 22, 2004
VOLUME VIEWER PLUS
K041521 · JAK
General Electric Medical Systems
Radiology · 14d
Cleared Jun 22, 2004
GE DISCOVERY ST
K041543 · KPS
Ge Healthcare
Radiology · 14d
Cleared Jun 22, 2004
COMPACS, VERSION 1.0
K041581 · LLZ
Intelligent Images Srl
Radiology · 8d
Cleared Jun 21, 2004
STARPACS ORTHOPEDICS SYSTEM
K041500 · LLZ
Infinitt Co., Ltd.
Radiology · 14d
Cleared Jun 18, 2004
MODIFICATION TO HENSCHKE HDR CERVIX APPLICATOR AND HILARIS/NORI HDR CERVIX...
K040704 · JAQ
Mick Radio-Nuclear Instruments, Inc.
Radiology · 92d
Cleared Jun 17, 2004
NOVA FAMILY OF MEDICAL RADIOLOGY DISPLAYS
K040310 · LLZ
National Display Systems
Radiology · 129d
Cleared Jun 17, 2004
NEUROQ - PET DP
K041022 · KPS
Syntermed, Inc.
Radiology · 58d
Cleared Jun 17, 2004
GE SIGNA EXCITE 1.5T MR SYSTEM, GE SIGNA EXCITE 3.0T MR SYSTEM
K041476 · LNH
Ge Medical Systems, LLC
Radiology · 14d
Cleared Jun 17, 2004
QD HEAD SPEEDER WITH SPEEDER NV ATTACHMENT
K041487 · MOS
Usa Instruments, Inc.
Radiology · 13d
Cleared Jun 17, 2004
CT-C3000DUAL AND CT-C2800DUAL FAMILY OF DUAL-SLICE CT SCANNER SYSTEMS
K041542 · JAK
Neusoft Digital Medical Systems Co.,...
Radiology · 9d
Cleared Jun 16, 2004
DOME CX DIGITAL FLAT-PANEL DISPLAY SYSTEM, MODEL C5I
K040443 · LLZ
Dome Imaging Systems, Inc.
Radiology · 117d
Cleared Jun 16, 2004
HEXAPOD RT COUCHTOP
K041448 · JAI
Medical Intelligence Medizintechnik GmbH
Radiology · 15d
Cleared Jun 15, 2004
OLINDA/EXM
K033960 · IYX
Vanderbilt University
Radiology · 176d
Cleared Jun 15, 2004
DIGORA OPTIME (OR DIGORA ONTIME)
K041050 · MUH
Soredex Palodex Group OY
Radiology · 54d
Cleared Jun 15, 2004
GE DISCOVERY ST SYSTEM
K041220 · KPS
GE Medical Systems
Radiology · 36d
Cleared Jun 10, 2004
AXIOM ARTIS U
K040675 · OWB
Siemens Medical Systems, Inc.
Radiology · 90d
Cleared Jun 10, 2004
21.3-INCH (54CM) COLOR LCD MONITOR CCL212 (CDL2107A)
K040697 · LLZ
Totoku Electric Co., Ltd.
Radiology · 85d