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
11665–11688 of 15,668
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Dec 22, 1994
MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY
K944112 · LNH
GE Medical Systems
Radiology · 121d
Cleared Dec 15, 1994
UNITONE
K934572 · LLZ
Scitex Corporation , Ltd.
Radiology · 450d
Cleared Dec 15, 1994
RF DRIVER, RADIO FREQUENCY DRIVER
K943406 · IYE
Pro-Comm, Inc.
Radiology · 154d
Cleared Dec 15, 1994
MERIT (O.1T MR SYSTEM)
K943415 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 153d
Cleared Dec 15, 1994
HUMPHREY OCT (OPTICAL COHERENCE TOMOGRAPHY) SCANNER
K944523 · IYO
Humphrey, Inc.
Radiology · 90d
Cleared Dec 15, 1994
MAVIG LOWER BODY PROTECTION SYSTEMS, ASSEMBLY MODELS 6265, 6266, 6267, 6268,...
K945238 · IWQ
F. Walter Hanel GmbH
Radiology · 49d
Cleared Dec 14, 1994
NRF SYSTEM
K944973 · JAA
Philips Medical Systems (Cleveland),...
Radiology · 64d
Cleared Dec 14, 1994
RHODIUM FILTER
K945272 · IZH
Lorad Corp.
Radiology · 47d
Cleared Dec 14, 1994
PHILIPS BUCKY DIAGNOST FAMILY
K945278 · KPR
Philips Medical Systems North...
Radiology · 47d
Cleared Dec 14, 1994
SII 360 MS
K945708 · KPR
Scott Imaging Intl., Inc.
Radiology · 23d
Cleared Dec 14, 1994
SII 525 MS
K945709 · KPR
Scott Imaging Intl., Inc.
Radiology · 23d
Cleared Dec 12, 1994
BES - BREATH EXPOSURE SYNCHRONIZER
K942581 · KPR
The Henry G. Dietz Co., Inc.
Radiology · 195d
Cleared Dec 09, 1994
MODEL 37-720 DUAL DIODE DOSIMETRY SYSTEM
K940660 · IYE
Victoreen, Inc.
Radiology · 297d
Cleared Dec 09, 1994
LENZAR REMOTE ACQUISITION SYSTEM
K941224 · LMD
Lenzar Electrooptics, Inc.
Radiology · 270d
Cleared Dec 09, 1994
VERSION 5 OPERATING SYSTEM SOFTWARE
K943799 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 128d
Cleared Dec 09, 1994
TOMO-LINK
K944967 · IZF
GE Medical Systems
Radiology · 59d
Cleared Dec 09, 1994
COMPAS
K945483 · IZI
General Electric Co.
Radiology · 31d
Cleared Dec 08, 1994
PHILIPS ULTRASOUND P800 IMAGING SYSTEM
K935923 · IYN
Hewlett-Packard Co.
Radiology · 360d
Cleared Dec 08, 1994
MODEL #300TO3500 SHOULDER COIL
K942874 · LNH
Medic, Inc.
Radiology · 174d
Cleared Dec 07, 1994
DIAGNOSTIC ULTRASOUND IMAGING CATHETER
K940108 · ITX
Boston Scientific Corp
Radiology · 331d
Cleared Dec 07, 1994
MEDVISION ENVIROMENT/MEDVISION 2.0
K942861 · LMD
Evergreen Technologies, Inc.
Radiology · 173d
Cleared Dec 07, 1994
MOTORIZED DEPTH DOSE APPARATUS
K943199 · IYE
Medtec, Inc.
Radiology · 155d
Cleared Dec 07, 1994
PANORAMIC CORPORATION HDLX
K943532 · JAA
Panoramic Corp.
Radiology · 139d
Cleared Dec 07, 1994
HP BACK POINTER SYSTEM
K943802 · IWE
Medtec, Inc.
Radiology · 125d