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
8689–8712 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Oct 09, 2003
PINNACLE3 RADIATION THERAPY PLANNING SYSTEM
K032724 · MUJ
Adac Laboratories
Radiology · 36d
Cleared Oct 08, 2003
GE 0.7T SIGNA OPENSPEED WITH EXCITE MR SYSTEM
K032795 · LNH
Ge Medical Systems, LLC
Radiology · 30d
Cleared Oct 08, 2003
WIDE 2MP TFT LCD MONITOR SYSTEM IF 1902A
K032960 · LLZ
Wide Corporation
Radiology · 15d
Cleared Oct 03, 2003
MOSFET AUTOSENSE WIRELESS
K032725 · IYE
Thomson & Nielsen Electronics, Ltd.
Radiology · 30d
Cleared Oct 02, 2003
3D INVIVO BY CSIST
K031567 · LLZ
Chung-Shan Institute of Science and...
Radiology · 136d
Cleared Oct 02, 2003
SECTRA ORTHOPEDIC PACKAGE
K031590 · LLZ
Sectra-Imtec AB
Radiology · 134d
Cleared Oct 02, 2003
I-BEAM
K032100 · IYE
Computerized Medical Systems, Inc.
Radiology · 86d
Cleared Oct 02, 2003
ALARA CRYSTALVIEW COMPUTED RADIOGRAPHY SYSTEM
K032210 · MQB
Alara, Inc.
Radiology · 73d
Cleared Oct 02, 2003
MINICAT DENTOCAT
K032243 · JAK
Xoran Technologies, Inc.
Radiology · 72d
Cleared Oct 02, 2003
ECHOENCODER
K032324 · LLZ
Icardiogram, Incorporated
Radiology · 66d
Cleared Oct 02, 2003
MICROMLC
K032790 · IXI
Siemens Medical Solutions USA, Inc.
Radiology · 24d
Cleared Sep 30, 2003
ALOKA MODEL SSD-5500 V6.0 ULTRASOUND SYSTEM
K032875 · IYO
Aloka Co. Ltd USA
Radiology · 15d
Cleared Sep 29, 2003
AIRIS ELITE MAGNETIC RESONANCE IMAGING DEVICE
K032232 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 70d
Cleared Sep 26, 2003
RAYCELL
K032684 · MOT
Mds Nordion
Radiology · 28d
Cleared Sep 25, 2003
RATTAN IMACS BY RATTAN INFORMATION CORPORATION
K032176 · LLZ
Rattan Information Corporation
Radiology · 71d
Cleared Sep 25, 2003
PRECISE CARBON FIBER TABLE TOP, MODEL 11-999
K032248 · IYE
Aktina Medical Physics Corp.
Radiology · 65d
Cleared Sep 25, 2003
ORTHORALIX 9200 DDE, ORTHORALIX 9200 DDE PLUS CEPH, MODELS 5105 0161WW, 5105...
K032355 · EHD
Dentsply Gendex
Radiology · 57d
Cleared Sep 25, 2003
EXOMIO, MODEL 2.0 SP1
K032550 · KPQ
Medcom GmbH
Radiology · 38d
Cleared Sep 25, 2003
HRK-63-8 KNEE ARRAY COIL
K032633 · MOS
Mri Devices Corp.
Radiology · 30d
Cleared Sep 24, 2003
TELEMIS-MEDICAL SOLUTION
K032157 · LLZ
Telemis S.A.
Radiology · 72d
Cleared Sep 24, 2003
DRYSTAR 5300 MEDICAL IMAGE PRINTER, MODEL 5300
K032635 · LMC
Agfa Corp.
Radiology · 29d
Cleared Sep 24, 2003
MODIFICATION TO: AURORA
K032678 · LNH
Aurora Imaging Technology, Inc.
Radiology · 26d
Cleared Sep 24, 2003
KONICA LASER IMAGER, MODEL DRYPRO MODEL 771
K032681 · LMC
Konica Medical and Graphic Corporation
Radiology · 26d
Cleared Sep 17, 2003
SIMUPLAN TREATMENT PLANNING SYSTEM, MODEL V. 7.5
K030821 · MUJ
Simuplan S.L.
Radiology · 187d