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
12529–12552 of 15,668
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jul 17, 1992
GENESYS II
K922080 · KPS
Adac Laboratories
Radiology · 74d
Cleared Jul 16, 1992
GE 4096 PLUS & GE 2048
K914267 · KPS
GE Medical Systems
Radiology · 297d
Cleared Jul 16, 1992
MRT-50A QD SPINE COIL
K921720 · LNH
Toshiba America Mri, Inc.
Radiology · 98d
Cleared Jul 13, 1992
CVIS INSIGHT III SYSTEM
K921750 · ITX
Cardiovascular Imaging Systems, Inc.
Radiology · 91d
Cleared Jul 10, 1992
MRT-150 QD KNEE COIL
K920096 · LNH
Toshiba America Mri, Inc.
Radiology · 184d
Cleared Jul 10, 1992
MRI OE 1.5 SI
K920543 · LNH
Otsuka Electronics
Radiology · 156d
Cleared Jul 10, 1992
MP3000 SERIES III VIDEO IMAGER
K921992 · LMC
International Imaging Electronics
Radiology · 79d
Cleared Jul 10, 1992
P-LINK
K922313 · KPS
Virtual Imaging
Radiology · 70d
Cleared Jul 02, 1992
CINE RECALL FUNCTION/OPUS 1 REAL TIME SCANNER
K915715 · IYO
Ausonics Pty , Ltd.
Radiology · 268d
Cleared Jul 02, 1992
LINEAR PERIPHERALVASCULAR ULTRSOUND PROBE
K915860 · ITX
Biosound, Inc.
Radiology · 185d
Cleared Jul 02, 1992
CVIS INSIGHT IMAGING CATHETER FOR INTRALUMINAL
K921631 · ITX
Cardiovascular Imaging Systems, Inc.
Radiology · 87d
Cleared Jul 01, 1992
CARDIOMETRICS FLOWIRE/FLOMAP SYSTEM
K921563 · ITX
Cardio Metrics, Inc.
Radiology · 91d
Cleared Jul 01, 1992
KODAK EKTASCAN 2180 LASER PRINTER
K921743 · LMC
Eastman Kodak Company
Radiology · 79d
Cleared Jul 01, 1992
AD/V SPOOLER
K921877 · LMD
Adaptive Video, Inc.
Radiology · 72d
Cleared Jul 01, 1992
SDMO APPLICATOR CODE: ASN.8236
K921961 · IWJ
Medi-Physics Inc. Dba Nycomed...
Radiology · 65d
Cleared Jul 01, 1992
DIGITIZER, MODEL # 3-000A-1518
K922619 · IZH
Lorad Medical Systems, Inc.
Radiology · 33d
Cleared Jun 30, 1992
ORWO X-RAY FILM
K920539 · IWZ
Burkhart Roentgen Intl., Inc.
Radiology · 146d
Cleared Jun 30, 1992
VFC UNIT
K920746 · JAA
Tilane Corp.
Radiology · 132d
Cleared Jun 26, 1992
DIAGNOSTIC ULTRASOUND SYSTEM TYPE 3535, MODIFIED
K914945 · IYO
Bruel & Kjaer Industri A/S
Radiology · 235d
Cleared Jun 25, 1992
B3000/B3000M MAGNETIC RESONANCE IMAGING SCANNER
K920789 · LNH
Fonar Corp.
Radiology · 125d
Cleared Jun 25, 1992
ACUSON IMAGE MANAGEMENT SYSTEM
K921670 · IYO
Acuson Corp.
Radiology · 78d
Cleared Jun 25, 1992
MKS BEAM OUTLINE PROJECTOR
K921876 · KPQ
Medical Knowledge Systems, Inc.
Radiology · 66d
Cleared Jun 24, 1992
MAESTRO DIGITAL VIDEO SYSTEM
K920373 · IYO
International Imaging Electronics
Radiology · 147d
Cleared Jun 24, 1992
STATVIEW
K921527 · LMD
Image Data Corp.
Radiology · 82d