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
9121–9144 of 15,433
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Nov 29, 2001
DRYSTAR, MODEL 4500M
K012941 · LMC
Agfa Corp.
Radiology · 90d
Cleared Nov 27, 2001
CARDIOVASCULAR ARRAY
K013810 · MOS
W.L. Gore & Associates, Inc.
Radiology · 12d
Cleared Nov 20, 2001
SIGNA OPENSPEED MAGNETIC RESONANCE SYSTEM
K012875 · LNH
GE Medical Systems
Radiology · 85d
Cleared Nov 20, 2001
HRH-127-ALLEGRA HEAD ARRAY COIL
K013508 · MOS
Mri Devices Corp.
Radiology · 29d
Cleared Nov 20, 2001
HNC-63-INT NEUROVASCULAR ARRAY COIL
K013602 · MOS
Mri Devices Corp.
Radiology · 20d
Cleared Nov 20, 2001
EFILM VIDEO
K013631 · LMA
Efilm Medical, Inc.
Radiology · 15d
Cleared Nov 16, 2001
SONOACE SA-8000 DIAGNOSTIC ULTRASOUND SYSTEM
K013627 · IYN
Medison America, Inc.
Radiology · 11d
Cleared Nov 15, 2001
DIGITAL RADIOGRAPHY SYSTEM, MODEL DFP-8000D
K013608 · OWB
Toshiba America Medical Systems, In.C
Radiology · 15d
Cleared Nov 14, 2001
ADC PEDIATRIC
K012750 · MQB
Agfa Corp.
Radiology · 90d
Cleared Nov 14, 2001
ALTAIR MODEL, DEI SYSTEM (DIFFRACTIVE ENERGY IMAGING SYSTEM)
K013291 · NCS
Advanced Diagnostics, Inc.
Radiology · 43d
Cleared Nov 13, 2001
SCANTAC MEMBRANE OR SCANTAC STRIP
K013170 · ITX
Sonotech, Inc.
Radiology · 50d
Cleared Nov 13, 2001
SSA-770A, APLIO ULTRASOUND SYSTEM
K013633 · IYO
Toshiba America Medical Systems, In.C
Radiology · 8d
Cleared Nov 09, 2001
STANDARD IMAGING IVB 1000 WELL CHAMBER
K013548 · KPT
Standard Imaging, Inc.
Radiology · 16d
Cleared Nov 08, 2001
IQUANTIFY, VERSION 1.0
K011196 · LLZ
Insightful Corporation
Radiology · 203d
Cleared Nov 08, 2001
MAROSIS PACS
K012844 · LLZ
Marotech, Inc.
Radiology · 77d
Cleared Nov 08, 2001
LIGHTSPEED 4.0 CT SCANNER SYSTEM
K013561 · JAK
GE Medical Systems
Radiology · 13d
Cleared Nov 07, 2001
GEMINI IMAGING SYSTEM
K013521 · JAK
Adac Laboratories
Radiology · 15d
Cleared Nov 07, 2001
SOMATOM P30 CT SYSTEMS
K013522 · JAK
Siemens Medical Systems, Inc.
Radiology · 15d
Cleared Nov 07, 2001
QWIKSIM VIRTUAL SIMULATION SYSTEM
K013531 · KPQ
Impac Medical Systems, Inc.
Radiology · 15d
Cleared Nov 06, 2001
MODIFICATION TO SKYLIGHT IMAGING SYSTEM
K013496 · KPS
Adac Laboratories
Radiology · 15d
Cleared Nov 02, 2001
OPTIMA URS UNIVERSAL RADIOGRAPHIC SYSTEM
K012546 · KPR
Sedecal USA, Inc.
Radiology · 87d
Cleared Nov 02, 2001
DEEP GRAY
K012563 · LLZ
Cortechs Labs, Inc.
Radiology · 85d
Cleared Nov 02, 2001
ICONNECTION 3D
K012779 · LLZ
Hinnovation, Inc.
Radiology · 74d
Cleared Nov 02, 2001
DUAL ENERGY AND TISSUE EQUALIZATION SOFTWARE OPTION
K013481 · KPR
GE Medical Systems
Radiology · 14d