FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology × Cleared only ×
15,520 results
12793–12816 of 15,520
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jun 07, 1991
KODAK 100-J & 100-K CHEMICAL MIXERS
K911713 · IXW
Eastman Kodak Company
Radiology · 51d
Cleared Jun 07, 1991
KODAK M35-MX-0MAT PROCESSOR
K911714 · IXW
Eastman Kodak Company
Radiology · 51d
Cleared Jun 06, 1991
STEREOTACTIC IRRADIATION SYSTEM
K904908 · IYE
Northwest Medical Physics Center
Radiology · 218d
Cleared Jun 06, 1991
SELECTOR MD (50KW AND 80 KW)
K910650 · IZO
Hofmann-Nagel Medical Systems, Inc.
Radiology · 112d
Cleared Jun 06, 1991
CINEMEASURE (TM)
K910654 · IZI
Syracuse Research Corp.
Radiology · 112d
Cleared Jun 06, 1991
PROBE REFILL KIT
K911073 · ITX
Interspec, Inc.
Radiology · 87d
Cleared Jun 04, 1991
INVOTEC X-RAY CASSETTE EQUIPMENT DRAPE
K911041 · IXA
Invotec International, Inc.
Radiology · 88d
Cleared May 30, 1991
ALPHA III PLUS AND MODEL P2500F/101 W/OPTIONAL
K896596 · IZH
Instrumentarium Imaging, Inc.
Radiology · 555d
Cleared May 30, 1991
COMPUTE-RX-COMP (TM)
K910367 · KPQ
Medicalibration Physics Consultant...
Radiology · 121d
Cleared May 30, 1991
MRP-5000 AND MRP-7000 MULTIPLANAR RECONSTRUCTION
K911642 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 49d
Cleared May 30, 1991
HITACHI MRP-7000 MAGNETIC ROSONANCE DEVICE
K911667 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 48d
Cleared May 28, 1991
L328 TRANSDUCER
K905456 · MAA
Acuson Corp.
Radiology · 175d
Cleared May 28, 1991
PHILIPS INTEGRIS V3000 AND V4000
K910370 · IZI
Philips Medical Systems, Inc.
Radiology · 119d
Cleared May 20, 1991
FRANKLIN 9000 WALL STAND
K905789 · KPX
Mallinckrodt Group, Inc.
Radiology · 144d
Cleared May 17, 1991
ECAT SCANNER
K910048 · KPS
Cti Pet Systems, Inc.
Radiology · 130d
Cleared May 17, 1991
COMPUTERIZED TOMOGRAPHY X-RAY SYSTEM
K910859 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 78d
Cleared May 17, 1991
KODAK EKTASCAN CABLE EXTENSION
K911437 · LMC
Eastman Kodak Company
Radiology · 45d
Cleared May 15, 1991
MODEL STT-100
K904853 · IYO
Sonocare, Inc.
Radiology · 198d
Cleared May 15, 1991
ADVANTX AFM ANGIO SYSTEM S1808
K905653 · IZI
GE Medical Systems
Radiology · 148d
Cleared May 15, 1991
QDR-1000 AND WITH X-RAY BONE DENSITOMETER
K905691 · KGI
Hologic, Inc.
Radiology · 147d
Cleared May 09, 1991
POWER SCAN 1000
K910802 · LNH
Webb Research, Inc.
Radiology · 72d
Cleared May 09, 1991
POSICAM SYSTEM MODEL 6.5 POSICAM-HZ SYSTEM
K911275 · KPS
Positron
Radiology · 48d
Cleared May 09, 1991
CT SYTEC 4000
K911387 · JAK
GE Medical Systems
Radiology · 41d
Cleared May 08, 1991
OMNICATH IMPLANTED CATHETER AND DEPOT
K911775 · KXK
Omnitron Intl., Inc.
Radiology · 37d