FDA 510(k) Regulatory Intelligence Search

Search devices, predicates, manufacturers and submission history used by regulatory affairs and medical device strategy teams.

174,883 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology × Cleared only ×
15,433 results
11593–11616 of 15,433
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jul 20, 1994
DDR WITH DPA AND 30/60 OPTIONS (DIGITAL VIEWSTATION)
K942264 · JAA
Eigen Video
Radiology · 72d
Cleared Jul 20, 1994
UNICATH FAMILY
K942503 · IZI
Angiographic Devices Corp.
Radiology · 55d
Cleared Jul 18, 1994
UNI-FRAME HEAD IMMOBILIZATION SYSTEM
K933227 · IYE
Medtec, Inc.
Radiology · 381d
Cleared Jul 18, 1994
VAC-LOK IMMOBILIZATION SYSTEM
K935300 · IYE
Medtec, Inc.
Radiology · 258d
Cleared Jul 18, 1994
MED-TEC, INC. BREAST BOARD, MT-250
K935411 · IYE
Medtec, Inc.
Radiology · 251d
Cleared Jul 18, 1994
MED-TEC, INC. BREAST BOARD, MT-200
K935412 · IYE
Medtec, Inc.
Radiology · 251d
Cleared Jul 18, 1994
VELO ACE
K940540 · IXW
Emix U.S.A., Inc.
Radiology · 161d
Cleared Jul 18, 1994
TEC 2101 (MODEL MT-HPLGD)
K941169 · IWE
Medtec, Inc.
Radiology · 126d
Cleared Jul 18, 1994
360 DEG. ROTATING 1/2 BEAM BLOCK
K941719 · IXI
Medtec, Inc.
Radiology · 102d
Cleared Jul 18, 1994
ADVANTAGE WINDOWS DIAGNOSTIC X-RAY WORKSTATION
K942120 · IZI
GE Medical Systems
Radiology · 76d
Cleared Jul 18, 1994
MED-TEC BREAST SUPPORT SYSTEM
K942282 · IYE
Medtec, Inc.
Radiology · 68d
Cleared Jul 05, 1994
SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-4800TF
K935487 · JAK
Shimadzu Corp.
Radiology · 232d
Cleared Jul 05, 1994
MRX-280
K942040 · JAK
Mrx Corp.
Radiology · 68d
Cleared Jun 28, 1994
DIAGNOSTIC ULTRASOUND SYSTEM, TYPE 3535, MODIFIED
K926332 · IYO
B&K Medical
Radiology · 589d
Cleared Jun 27, 1994
VENUS DIAGNOSTIC ULTRASOUND SYSTEM
K933202 · IYN
GE Medical Systems
Radiology · 361d
Cleared Jun 27, 1994
VOLUME NECK COIL FOR THE GYREX V-DIX
K935224 · LNH
Elscint, Inc.
Radiology · 238d
Cleared Jun 27, 1994
PACSPRO II
K941086 · LMD
Advanced Video Products, Inc.
Radiology · 111d
Cleared Jun 27, 1994
MEDICAL IMAGING WORKSTATION II (MIW II)
K941203 · LMD
Cemco, Inc.
Radiology · 105d
Cleared Jun 24, 1994
PHILIPS ENDO-CAVITARY MRI COIL
K930193 · LNH
Philips Medical Systems, Inc.
Radiology · 526d
Cleared Jun 24, 1994
MULTI DOPPLEX II / FETAL DOPPLEX II
K930200 · KNG
Huntleigh Healthcare, Inc.
Radiology · 526d
Cleared Jun 24, 1994
DIAGNOSTIC ULTRASOUND SYSTEM TYPE 3535, MODIFIED
K933056 · IYO
B&K Medical
Radiology · 372d
Cleared Jun 21, 1994
SEARCH-SONIC
K934205 · IYO
Altana, Inc.
Radiology · 295d
Cleared Jun 21, 1994
CATCH AND HOLD OPTION FOR INSTASCAN
K934514 · LNH
Advanced Nmr Systems, Inc.
Radiology · 279d
Cleared Jun 21, 1994
MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY
K940364 · LNH
Medical Advances, Inc.
Radiology · 146d