FDA 510(k) Regulatory Intelligence Search

Search devices, predicates, manufacturers and submission history used by regulatory affairs and medical device strategy teams.

174,883 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology × Cleared only ×
15,433 results
11569–11592 of 15,433
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Aug 09, 1994
LASER ALIGNMENT TOOL
K943381 · IWE
Philips Medical Systems North...
Radiology · 27d
Cleared Aug 01, 1994
MODEL GP-252 GENERAL PURPOSE COIL
K935691 · LNH
Diagnostic Instrument Corp.
Radiology · 245d
Cleared Jul 29, 1994
ANGIOCT OPTION FOR CT-TWIN, HELICAT & OMNIVIEW
K932508 · JAK
Elscint, Inc.
Radiology · 430d
Cleared Jul 29, 1994
NUCLEAR ASSOC 37-08 SER, RAYCAST HP RADIO IMMOB SYST
K935435 · IYE
Victoreen, Inc.
Radiology · 261d
Cleared Jul 29, 1994
RIT 113 FILM ANALYSIS SYSTEM
K935928 · IYE
Radiological Imaging Technology, Inc.
Radiology · 228d
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