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
8785–8808 of 15,433
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Dec 20, 2002
DUAL-ENERGY VERTEBRAL ASSESSMENT VIEW SOFTWARE
K023554 · KGI
Ge Lunar Corp.
Radiology · 58d
Cleared Dec 20, 2002
MODIFICATION TO MEDIPRIME
K023936 · LLZ
Algotec Systems, Ltd.
Radiology · 24d
Cleared Dec 19, 2002
PHILIPS EASYVISION WORKSTATION RELEASE 6
K023137 · LLZ
Philips Medical Systems North America...
Radiology · 90d
Cleared Dec 19, 2002
ECHO SOUNDER, ES-102EX
K023143 · KNG
Koven Technology, Inc.
Radiology · 90d
Cleared Dec 18, 2002
ALOKA SSD-3500 ULTRASOUND SYSTEM
K023996 · IYN
Aloka Co., Ltd.
Radiology · 15d
Cleared Dec 17, 2002
ISOROD PD-103 IMPLANT, MODEL ATI-PD-103
K020683 · KXK
Ati Medical, Inc.
Radiology · 288d
Cleared Dec 16, 2002
MODEL 472GE-128: QUADRATURE LOWER EXTREMITY COIL
K023084 · MOS
Medical Advances, Inc.
Radiology · 90d
Cleared Dec 13, 2002
BARCO MEDIS 2MP1NT MEDICAL DIAGNOSTIC DISPLAY SYSTEM
K022773 · LLZ
Barco N.V.
Radiology · 114d
Cleared Dec 13, 2002
S.O.F.T. PADDLE (SPECIAL OPTIMIZED FULL COMPRESSION TRAY), MODEL SFT-PDLE
K023229 · IZH
American Mammographics, Inc.
Radiology · 77d
Cleared Dec 13, 2002
APEX HRI DIGITAL RADIOGRAPHY SYSTEM
K023292 · MUH
Krugman Technologies, Inc.
Radiology · 72d
Cleared Dec 12, 2002
SONOSITE HAND-CARRIED ULTRASOUND SYSTEM (C2 SERIES)
K023957 · IYN
Sonosite,Inc.
Radiology · 15d
Cleared Dec 11, 2002
HUDSON 2020, 2040, 2060,ULTRASOUND SCANNERS
K022928 · IYO
Hudson Diagnostic Imaging, LLC
Radiology · 98d
Cleared Dec 11, 2002
GE PHOTON ENERGY RECOVERY (PER) OPTION
K023932 · KPS
Ge Medical Systems F.I. Haifa
Radiology · 15d
Cleared Dec 04, 2002
I-PLANT MODEL 3500 (125IODINE BRACHYTHERAPY SEEDS)-STERILE
K023242 · KXK
Implant Sciences Corp.
Radiology · 65d
Cleared Dec 02, 2002
MODEL AMI1200 C-ARM
K022911 · JAA
Integrity Practice Management, Inc.
Radiology · 90d
Cleared Nov 26, 2002
INNOVA 4100
K023178 · OWB
Ge Medical Systems, Inc.
Radiology · 64d
Cleared Nov 26, 2002
MY BREAST FRIEND, BREAST SELF-EXAM PAD
K023390 · IXH
Mbf Sales, LLC
Radiology · 48d
Cleared Nov 25, 2002
ECAT PET/CT
K023768 · KPS
Cti Pet Systems, Inc.
Radiology · 13d
Cleared Nov 22, 2002
PHILIPS INTEGRIS ALLURA FLAT DETECTOR RELEASE 1.0
K022899 · JAA
Philips Medical Systems North America...
Radiology · 80d
Cleared Nov 22, 2002
AMICAS LIGHT BEAM WORKSTATION, MODEL 1.0
K022970 · LLZ
Amicas, Inc.
Radiology · 77d
Cleared Nov 22, 2002
CEDARS-SINAI MOTION CORRECTION (MOCO) SOFTWARE, MODEL 111005
K023110 · KPS
Digirad Corp.
Radiology · 64d
Cleared Nov 22, 2002
BLOCKING TRAY
K023636 · IYE
Southeastern Radiation Products, Inc.
Radiology · 23d
Cleared Nov 22, 2002
SOMATOM EMOTION 6 CT SYSTEMS
K023687 · JAK
Siemens Medical Systems, Inc.
Radiology · 21d
Cleared Nov 22, 2002
CANNON DIGITAL RADIOGRAPHY MODEL CXDI-40G
K023750 · MQB
Canon USA, Inc.
Radiology · 14d