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
10441–10464 of 15,433
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Sep 15, 1997
MAGNETIC RESONANCE DIAGNOSTIC SYSTEM
K972296 · MOS
Ge Medical Systems, Inc.
Radiology · 88d
Cleared Sep 15, 1997
SIEMENS ORTHOPHOS DS/DS CEPH
K972312 · EHD
Siemens AG
Radiology · 87d
Cleared Sep 15, 1997
2T PRESTIGE(100-6321-0107)/PRIVILEGE(100-6326-0102)/GYREX V-EP(100-6327-0101)
K972592 · MOS
Elscint, Inc.
Radiology · 66d
Cleared Sep 12, 1997
ORTHOPHOS PLUS AND ORTHOPHOS PLUS/CD
K972249 · EHD
Pelton & Crane Co.
Radiology · 88d
Cleared Sep 12, 1997
FCR FUJI COMPUTED RADIOGRAPHY DMS CRT IMAGE CONSOLE HI-C654 (FOR NETWORKS)
K972256 · LLZ
Fujifilm Medical System U.S.A., Inc.
Radiology · 88d
Cleared Sep 11, 1997
INFIMED DENTAL SYSTEM
K962422 · EHD
Infimed, Inc.
Radiology · 444d
Cleared Sep 11, 1997
KODAK DIGITAL SCIENCE (KDS) MEDICAL IMAGE AND INFORMATION LIBRARY (MIIL)
K972380 · LMB
Eastman Kodak Company
Radiology · 77d
Cleared Sep 11, 1997
CEILING MOUNTED LATERAL POSITIONER, MODEL NO. 6896.002
K972442 · JAA
Continental X-Ray Corp.
Radiology · 73d
Cleared Sep 10, 1997
MULTIDOS, QC6PLUS
K972211 · LHN
Ptw-New York Corp.
Radiology · 90d
Cleared Sep 10, 1997
0.015CC PINPOINT IONIZATION CHAMBER, 0.005 CC PINPOINT IONIZATION CHAMBER
K972212 · LHN
Ptw-New York Corp.
Radiology · 90d
Cleared Sep 08, 1997
LOGIQ 1000 DIAGNOSTIC ULTRSOUND SYSTEM
K960527 · IYN
GE Medical Systems
Radiology · 580d
Cleared Sep 08, 1997
DIGITIZER DIRECTOR (HSC025-01)
K972191 · LMD
Howtek, Inc.
Radiology · 90d
Cleared Sep 08, 1997
LANTIS TREATSTATION
K972275 · IYE
Siemens Medical Solutions USA, Inc.
Radiology · 82d
Cleared Sep 08, 1997
CEQUAL-QUANTITATIVE ANALYSIS FOR CARDIOLITE EXECUTING ON THE MEDASYS DIGITAL...
K972509 · KPS
Nuccardiac Software, Inc.
Radiology · 67d
Cleared Sep 05, 1997
P REFERENCE TPS (TREATMENT PLANNING SOFTWARE) 1.1
K970464 · IYE
Northwest Medical Physics Equipment,...
Radiology · 210d
Cleared Sep 05, 1997
IMATION SE-196 LASER IMAGER
K972163 · LMC
Imation Corp.
Radiology · 88d
Cleared Sep 05, 1997
SIDEXIS DIGITAL RADIOGRAPHY SYSTEM
K972168 · EHD
Pelton & Crane Co.
Radiology · 88d
Cleared Sep 05, 1997
ALPHA 7000 QUADRATURE WRIST COIL
K972205 · MOS
Usa Instruments, Inc.
Radiology · 85d
Cleared Sep 04, 1997
E. CAM COINCIDENCE MODE (CM)
K970627 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 197d
Cleared Sep 03, 1997
VIEW ARCHIVING STATION
K971176 · IZI
Electromed Intl., Ltd.
Radiology · 156d
Cleared Sep 03, 1997
FLY THROUGH
K971717 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 117d
Cleared Sep 02, 1997
PHILIPS EASYVISION
K972103 · LLZ
Philips Medical Systems North...
Radiology · 90d
Cleared Sep 02, 1997
ARRIPRO 35 ST/TV
K973115 · IXC
Arnold & Richter Cine Technik
Radiology · 13d
Cleared Aug 25, 1997
GYREX PRIMA 1TG 1.0T MRI SYSTEM
K970990 · LNH
Elscint Mr, Inc.
Radiology · 160d