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
11809–11832 of 15,668
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jul 29, 1994
ORTHOPHOS 3/ ORTHOPHOS 3C
K936068 · EAP
Pelton & Crane Co.
Radiology · 220d
Cleared Jul 29, 1994
NOVA MICROSONICS ACCESS IMAGE MANAGEMENT NETWORK/ACCESS ACQUISITION MODULE
K940423 · LMD
Advanced Technology Laboratories, Inc.
Radiology · 179d
Cleared Jul 29, 1994
CTS SYSTEM
K941004 · IYB
Acoma Medical Imaging, Inc.
Radiology · 150d
Cleared Jul 29, 1994
F/C/W TUBESTAND
K941017 · IYB
Acoma Medical Imaging, Inc.
Radiology · 148d
Cleared Jul 29, 1994
TSX-002A (XVISION) CT SCANNER
K941745 · JAK
Toshiba America Medical Systems, In.C
Radiology · 113d
Cleared Jul 29, 1994
ISG MEDICAL IMAGING FAMILY OF WORKSTATIONS (MIFW)
K941933 · LLZ
I.S.G. Technologies, Inc.
Radiology · 100d
Cleared Jul 29, 1994
DPD-3
K942092 · IYE
Scanditronix, Inc.
Radiology · 88d
Cleared Jul 29, 1994
SNAC (SIEMENS NUCLEAR ACQUISITION COMPUTER)
K942116 · KPS
Siemens Corp.
Radiology · 87d
Cleared Jul 29, 1994
FUJI ULTIMA EC-MA CASSETTE
K942481 · IXA
Fujifilm Medical System U.S.A., Inc.
Radiology · 65d
Cleared Jul 29, 1994
ANGIOREST TABLE PAD SYSTEM
K942674 · JAA
Scribner Browne Medical Design, Inc.
Radiology · 53d
Cleared Jul 29, 1994
MODEL VPW2877F8, MAMMO 5 POWER SUPPLY
K942778 · IZO
Varian Assoc., Inc.
Radiology · 46d
Cleared Jul 29, 1994
BUCKY STAND BR-10M
K942792 · KPR
Shimadzu Corp.
Radiology · 45d
Cleared Jul 29, 1994
KYOKKO BLUE SERIES INTENSIFYING SCREENS
K942805 · EAM
Fujifilm Medical System U.S.A., Inc.
Radiology · 44d
Cleared Jul 29, 1994
KODAK INSIGHT TWIN-LOAD INSERT
K942909 · EAM
Eastman Kodak Company
Radiology · 38d
Cleared Jul 28, 1994
MERIT
K941408 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 127d
Cleared Jul 26, 1994
THERAPLAN V05B/ TP-11 V09B
K940237 · IYE
Theratronics, Inc.
Radiology · 189d
Cleared Jul 22, 1994
BRAINLAB LINAC HARDWARE
K934657 · IYE
Brainlab Med. Computersysteme GmbH
Radiology · 304d
Cleared Jul 20, 1994
PHANTOM
K941363 · IZL
Dynarad Corp.
Radiology · 121d
Cleared Jul 20, 1994
CRONEX REGULAR CASSETTE
K941475 · IXA
Dupont Medical Products
Radiology · 114d
Cleared Jul 20, 1994
DDR WITH DPA AND 30/60 OPTIONS (DIGITAL VIEWSTATION)
K942264 · JAA
Eigen Video
Radiology · 72d
Cleared Jul 20, 1994
UNICATH FAMILY
K942503 · IZI
Angiographic Devices Corp.
Radiology · 55d
Cleared Jul 18, 1994
UNI-FRAME HEAD IMMOBILIZATION SYSTEM
K933227 · IYE
Medtec, Inc.
Radiology · 381d
Cleared Jul 18, 1994
VAC-LOK IMMOBILIZATION SYSTEM
K935300 · IYE
Medtec, Inc.
Radiology · 258d
Cleared Jul 18, 1994
MED-TEC, INC. BREAST BOARD, MT-250
K935411 · IYE
Medtec, Inc.
Radiology · 251d