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
8857–8880 of 15,433
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Oct 11, 2002
BBC-63-GE BREAST ARRAY COIL
K023164 · MOS
Mri Devices Corp.
Radiology · 18d
Cleared Oct 09, 2002
EZ-SCOPE AN, EZ-SCOPE LIGHT
K022342 · IYX
Anzai Medical Co., Ltd.
Radiology · 83d
Cleared Oct 09, 2002
MODIFICATION TO FOCUS
K022630 · EHD
Instrumentarium Corp.
Radiology · 63d
Cleared Oct 09, 2002
OPART (INCLUDING OPART ULTRA AND ULTRA GRADIENT UPGRADE KIT)
K023207 · LNH
Toshiba America Medical Systems, In.C
Radiology · 14d
Cleared Oct 08, 2002
FOCUS RADIATION TREATMENT PLANNING SYSTEM
K020027 · MUJ
Computerized Medical Systems, Inc.
Radiology · 277d
Cleared Oct 08, 2002
ARTEMIS
K021333 · IYO
Ultralink, LLC
Radiology · 165d
Cleared Oct 08, 2002
KONRAD, MODEL V.2.0
K022307 · MUJ
Mrc Systems GmbH
Radiology · 84d
Cleared Oct 08, 2002
INNOVA AND INNOVA 2000 S
K022322 · OWB
Ge Medical Systems, Inc.
Radiology · 83d
Cleared Oct 08, 2002
TELSTAR BIPLANE DIGITAL IMAGING SYSTEM [TIS] MODEL 030-000915
K022565 · JAA
Stereotaxis, Inc.
Radiology · 67d
Cleared Oct 07, 2002
EXOMIO, MODEL 1.1
K022219 · KPQ
Medcom GmbH
Radiology · 90d
Cleared Oct 04, 2002
CANON X-RAY DIGITAL CAMERA WITH ADDITIONAL SOFTWARE, LANMIX MLT
K023124 · MQB
Canon, Inc.
Radiology · 15d
Cleared Oct 03, 2002
CSV12 SOFTWARE VIEWER
K022896 · LLZ
Acuson Corp.
Radiology · 30d
Cleared Oct 03, 2002
QSC-63-INT SHOULDER ARRAY COIL SET
K022910 · MOS
Mri Devices Corp.
Radiology · 30d
Cleared Oct 02, 2002
MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM
K022953 · MUH
Schick Technologies, Inc.
Radiology · 27d
Cleared Oct 01, 2002
MENTOR ISOLOADER AUTOMATIC NEEDLE LOADING SYSTEM AND PHYSICS WORKSTATION FOR...
K011493 · KPT
Mentor Corp.
Radiology · 504d
Cleared Sep 30, 2002
LEVEL 356 X-RAY FILM PROCESSOR, MODELS MD & MD-D
K022154 · IXW
Fischer Industries, Inc.
Radiology · 90d
Cleared Sep 27, 2002
MED-TEC COMPENSATOR BLOCK CUTTER SOFTWARE
K013875 · IXI
Med-Tec,Inc.
Radiology · 308d
Cleared Sep 27, 2002
HRK-63 KNEE ARRAY COIL
K022883 · MOS
Mri Devices Corp.
Radiology · 28d
Cleared Sep 26, 2002
AGFA MAMORAY MAMMOGRAPHIC CASSETTE, AGFA METAL-BODIED CAWO CASSETTE, AGFA...
K023020 · IXA
Agfa Corp.
Radiology · 15d
Cleared Sep 26, 2002
TRANSVAGINAL DOPPLER PROBE, MODEL 09-0006-02
K023024 · ITX
Vascular Control Systems, Inc.
Radiology · 15d
Cleared Sep 20, 2002
PRECISEPLAN 2.0
K022411 · MUJ
Precision Therapy Intl., Inc.
Radiology · 58d
Cleared Sep 19, 2002
SMART BREATH RESPIRATORY COMPENSATION OPTION
K022919 · JAK
GE Medical Systems
Radiology · 15d
Cleared Sep 19, 2002
GE QUASAR NUCLEAR MEDICINE SYSTEM
K022960 · KPS
Ge Medical Systems F.I. Haifa
Radiology · 13d
Cleared Sep 17, 2002
OEC FLUOROTRAK 9800 PLUS
K022069 · OWB
Ge Oec Medical Systems
Radiology · 84d