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.

176,325 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology ×
15,668 results
10657–10680 of 15,668
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Oct 08, 1997
ROTOGRAPH PLUS
K972968 · EHD
Chicago X-Ray Systems, Inc.
Radiology · 58d
Cleared Oct 08, 1997
DRTS IMAGE INTENSIFIER DRAPE
K973073 · JAA
Minrad, Inc.
Radiology · 51d
Cleared Oct 08, 1997
MAMMOLOADER BY C.M.A. SRL
K973125 · IXW
C.M.A.
Radiology · 49d
Cleared Oct 08, 1997
AMBER DU
K973219 · KPR
Oldelft Corp. of America
Radiology · 42d
Cleared Oct 08, 1997
SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-6800TH
K973327 · JAK
Shimadzu Medical Systems
Radiology · 34d
Cleared Oct 08, 1997
SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-6800TX
K973329 · JAK
Shimadzu Medical Systems
Radiology · 34d
Cleared Oct 08, 1997
DAR-3000B
K973342 · IZI
Shimadzu Corp.
Radiology · 33d
Cleared Oct 07, 1997
KODAK DIGITAL SCIENCE 9000D MEDICAL LASER PRINTER (9000D)
K972847 · LMC
Eastman Kodak Company
Radiology · 67d
Cleared Oct 03, 1997
GE LOGIQ 700 DIAGNOSTIC ULTRASOUND SYSTEM
K964617 · IYO
GE Medical Systems
Radiology · 340d
Cleared Oct 03, 1997
EXPERT-XL TOTAL BODY ACQUISITION AND ANALYSIS SOFTWARE
K965226 · KPS
Lunar Corp.
Radiology · 277d
Cleared Oct 01, 1997
COLORPOINT OR PROFESSIONAL COLORPOINT
K971760 · LMC
Seiko Instruments USA, Inc.
Radiology · 142d
Cleared Oct 01, 1997
HELAX-VISIR
K972617 · IYE
Helax AB
Radiology · 84d
Cleared Oct 01, 1997
MIRAGE
K972886 · LLZ
Segami Corp., Inc.
Radiology · 57d
Cleared Oct 01, 1997
NEEDLE GUIDE/GRID
K973362 · ITX
Protek Medical Products, Inc.
Radiology · 23d
Cleared Sep 29, 1997
OPTIVIEW
K972520 · LLZ
Optimed Technologies, Inc.
Radiology · 84d
Cleared Sep 29, 1997
KINEMATIC POSITIONERS
K972704 · LNH
Ge Medical Systems, Inc.
Radiology · 73d
Cleared Sep 23, 1997
MULTISPECT 2 511 KEV COLLIMATOR
K972360 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 90d
Cleared Sep 23, 1997
IMNET DICOM NETWORK AGENT
K972366 · LMD
Imnet Systems, Inc.
Radiology · 90d
Cleared Sep 23, 1997
ADVANTAGE WINDOWS VOLUME RENDERING OPTION
K972399 · JAK
Ge Medical Systems, Inc.
Radiology · 89d
Cleared Sep 15, 1997
MAGNETIC RESONANCE DIAGNOSTIC SYSTEM
K972296 · MOS
Ge Medical Systems, Inc.
Radiology · 88d
Cleared Sep 15, 1997
SIEMENS ORTHOPHOS DS/DS CEPH
K972312 · EHD
Siemens AG
Radiology · 87d
Cleared Sep 15, 1997
2T PRESTIGE(100-6321-0107)/PRIVILEGE(100-6326-0102)/GYREX V-EP(100-6327-0101)
K972592 · MOS
Elscint, Inc.
Radiology · 66d
Cleared Sep 12, 1997
ORTHOPHOS PLUS AND ORTHOPHOS PLUS/CD
K972249 · EHD
Pelton & Crane Co.
Radiology · 88d
Cleared Sep 12, 1997
FCR FUJI COMPUTED RADIOGRAPHY DMS CRT IMAGE CONSOLE HI-C654 (FOR NETWORKS)
K972256 · LLZ
Fujifilm Medical System U.S.A., Inc.
Radiology · 88d