FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology ×
15,620 results
10441–10464 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Apr 01, 1998
LEKSELL GAMMAPLAN
K973441 · IWB
Patterson Consulting Group, Inc.
Radiology · 202d
Cleared Mar 30, 1998
SHIELDED CABINET X-RAY RADIATION SOURCE DEVICE MODEL RS 3000
K974210 · MOT
Rad-Source, Inc.
Radiology · 140d
Cleared Mar 30, 1998
MAGNETIC RESONANCE DIAGNOSTIC SYSTEM
K980114 · LNH
GE Medical Systems
Radiology · 76d
Cleared Mar 27, 1998
CRANEX TOME CEPH, OR CRANEX TOME
K974877 · EHD
Orion Corporation Soredex
Radiology · 88d
Cleared Mar 23, 1998
THE TCS-MEDCON'S TELECARDIOLOGY SYSTEM
K974679 · IZI
Medcon , Ltd.
Radiology · 98d
Cleared Mar 23, 1998
TRIMAX RADIOGRAPHIC CASSETTE
K980722 · IXA
Imation Corp.
Radiology · 27d
Cleared Mar 19, 1998
LD2000 SERIES
K980565 · LMA
General Scanning, Inc.
Radiology · 34d
Cleared Mar 18, 1998
ASU-1000 DIAGNOSTIC ULTRASOUND TRANSDUCER
K974544 · ITX
Aloka Co., Ltd.
Radiology · 104d
Cleared Mar 17, 1998
IMIX DIGITAL THORAX SYSTEM
K974863 · KPR
Advanced Instrument Development, Inc.
Radiology · 78d
Cleared Mar 17, 1998
KODAK DIGITAL SCIENCE ONCOLOGY IMAGE MANAGER
K980118 · LLZ
Eastman Kodak Company
Radiology · 63d
Cleared Mar 17, 1998
DI-2000
K980213 · LMA
Lumisys, Inc.
Radiology · 67d
Cleared Mar 17, 1998
NETCO MEDICAL DATA TRANSPORTATION SERVICE SOFTWARE
K980241 · LMD
Netco Communications Corp.
Radiology · 53d
Cleared Mar 10, 1998
CARBON FIBER BREAST BOARD
K974703 · IYE
Medtec, Inc.
Radiology · 84d
Cleared Mar 10, 1998
OUTLOOK SYSTEM ENHANCEMENT PACKAGE
K974844 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 76d
Cleared Mar 09, 1998
ADC COMPACT (AGFA DIAGNOSTIC CENTER)
K974597 · KPR
Bayer Corp., Agfa Div.
Radiology · 90d
Cleared Mar 04, 1998
SHIMASONIC LINEAR/CONVEX DIAGNOSTIC ULTRASOUND SYSTEM
K973802 · IYO
Shimadzu Medical Systems
Radiology · 149d
Cleared Mar 04, 1998
GYREX 2T PRESTIGE 100-6321-0107, GYREX PRIVILEDGE 100-6326-0102, GYREX PRIMA...
K974614 · LNH
Elscint, Inc.
Radiology · 83d
Cleared Mar 04, 1998
MATRIX MT-MX3
K974700 · IYE
Medtec, Inc.
Radiology · 78d
Cleared Mar 04, 1998
DYNA VUE 3-D IMAGING PRODUCT
K974755 · LLZ
Imd Systems, Inc.
Radiology · 75d
Cleared Feb 27, 1998
EPS
K974504 · LLZ
E For M Imaging Systems Div.,...
Radiology · 88d
Cleared Feb 26, 1998
STRATIS II
K974498 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 90d
Cleared Feb 25, 1998
ECAT PET SCANNERS
K974256 · KPS
Cti Pet Systems, Inc.
Radiology · 104d
Cleared Feb 25, 1998
3D I-SCAN
K974522 · IYO
Ophthalmic Technologies, Inc.
Radiology · 85d
Cleared Feb 25, 1998
SCANARAY/CD-DENT ADVANCED COMPUTERIZED X-RAY SYSTEM
K974619 · LMA
Afp Imaging Corp.
Radiology · 76d