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
9169–9192 of 15,433
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Oct 01, 2001
DOSERIGHT
K012238 · JAK
Philips Medical Systems North America...
Radiology · 76d
Cleared Oct 01, 2001
CTS-485 ULTRASOUND IMAGING SYSTEM
K012772 · IYO
Shantou Institute of Ultrasonic...
Radiology · 45d
Cleared Oct 01, 2001
EXHALE PROBE
K013111 · EOQ
Broncus Technologies, Inc.
Radiology · 13d
Cleared Sep 28, 2001
RAPIDIA
K012290 · LLZ
3D Med Co., Ltd.
Radiology · 70d
Cleared Sep 28, 2001
ADC COMPACT PLUS
K013138 · MQB
Agfa-Gevaert AG
Radiology · 9d
Cleared Sep 27, 2001
NUMARIS 4VA15A
K012202 · LNH
Siemens Medical Corp.
Radiology · 76d
Cleared Sep 26, 2001
SONOREAL 3D
K012084 · IYO
Bio Medi Com
Radiology · 85d
Cleared Sep 25, 2001
ACCUIMAGE SMARTGATE UPGRADE
K012106 · JAK
Accuimage Diagnostics Corp.
Radiology · 81d
Cleared Sep 25, 2001
MODIFICATION TO: QWH-420 WRIST ARRAY COIL
K013099 · MOS
Mri Devices Corp.
Radiology · 8d
Cleared Sep 24, 2001
GE SIGNA ASSET IMAGING OPTION
K012970 · LNH
GE Medical Systems
Radiology · 20d
Cleared Sep 21, 2001
INTRA OPERATIVE RADIATION THERAPY
K004023 · IYE
Arplay Medical S.A.
Radiology · 268d
Cleared Sep 21, 2001
AETMED IMAGE PROCESSING SOFTWARE
K012093 · LLZ
Aetmed, S.P.A.
Radiology · 78d
Cleared Sep 20, 2001
MODIFICATION TO LR 5200 FILM RECORDER
K012010 · LMC
Agfa Corp.
Radiology · 85d
Cleared Sep 19, 2001
AURORA MAGNETIC RESONANCE DIAGNOSTIC DEVICE
K012154 · LNH
Aurora Imaging Technology, Inc.
Radiology · 70d
Cleared Sep 19, 2001
OLDELFT THORASCAN MODEL NUMBER 180T
K012165 · KPR
Nucletron Corp.
Radiology · 70d
Cleared Sep 18, 2001
GE POSITRACE/DISCOVERY VI PET/CT DUAL MODE ONCOLOGY SCANNER
K012775 · KPS
GE Medical Systems
Radiology · 29d
Cleared Sep 13, 2001
MX8000 IDT CT SYSTEM
K012009 · JAK
Marconi Medical Systems, Inc.
Radiology · 78d
Cleared Sep 13, 2001
AQUARIUSNET SERVER
K012086 · LLZ
Terarecon,Inc.
Radiology · 72d
Cleared Sep 12, 2001
SONOACE 9900 DIAGNOSTIC ULTRASOUND SYSTEM
K012867 · IYN
Medison America, Inc.
Radiology · 16d
Cleared Sep 12, 2001
SA6000II DIAGNOSTIC ULTRASOUND SYSTEM
K012887 · IYO
Medison America, Inc.
Radiology · 15d
Cleared Sep 07, 2001
MINI MULTILEAF COLLIMATOR, MODEL KMI
K011816 · IXI
Mrc Systems GmbH
Radiology · 88d
Cleared Sep 07, 2001
MODIFICATION TO: LIGHTSPEED PLUS MOBILE CT SYSTEM
K012836 · JAK
GE Medical Systems
Radiology · 15d
Cleared Sep 06, 2001
GE VISION NUCLEAR MEDICINE WORKSTATION
K012568 · KPS
General Electric Co.
Radiology · 28d
Cleared Sep 05, 2001
OMNIDOS
K011763 · IYE
Scanditronix Medical AB
Radiology · 90d