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
11209–11232 of 15,520
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Sep 20, 1995
FUJI COMPUTED RADIOGRAPHY SYSTEM FCR9501ES.FCR
K952862 · LLZ
Fujifilm Medical System U.S.A., Inc.
Radiology · 90d
Cleared Sep 19, 1995
GYRES 2T PRESTIGE
K945791 · LNH
Elscint, Inc.
Radiology · 298d
Cleared Sep 18, 1995
LP-12 LAPAROSCOPIC PROBE
K941935 · ITX
Biosound, Inc.
Radiology · 516d
Cleared Sep 18, 1995
OUTLOOK
K945827 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 293d
Cleared Sep 18, 1995
OLYMPUS IMAGEMANAGER SYSTEM VERSION 6.0 FOR WINDOWS
K952888 · LMB
Olympus America, Inc.
Radiology · 87d
Cleared Sep 18, 1995
STAR TECHNOLOGIES, INC. FILM IMAGE SCAN SYSTEM
K952914 · LMD
Star Technologies, Inc.
Radiology · 84d
Cleared Sep 18, 1995
FLUORO CATHETER
K953950 · JAA
Cmt Medical Technologies, Ltd.
Radiology · 27d
Cleared Sep 18, 1995
LUMISYS, LUMISCAN 20
K953964 · LMA
Lumisys, Inc.
Radiology · 27d
Cleared Sep 15, 1995
TOMTECP90
K950279 · LMB
Tomtec Imaging Systems, Inc.
Radiology · 234d
Cleared Sep 15, 1995
UST-5268P-5 TRANSDUCER
K950607 · KRK
Aloka Co., Ltd.
Radiology · 218d
Cleared Sep 15, 1995
PAINTED WEDGE & ROD BREAST BOARD
K952729 · IYE
Medtec, Inc.
Radiology · 92d
Cleared Sep 13, 1995
KODAK EKTASCAN TRIAD LASER PRINTER SYSTEM, PHOTON LASER PRINTER
K951807 · LMC
Kodak Health Imaging Systems, Inc.
Radiology · 147d
Cleared Sep 13, 1995
KODAK XLS 8600 (PS)
K951948 · LMC
Kodak Health Imaging Systems, Inc.
Radiology · 140d
Cleared Sep 12, 1995
SOLARIX FV
K953832 · KPR
GE Medical Systems
Radiology · 27d
Cleared Sep 12, 1995
MAGNETIC RESONANCE DIAGNOSTIC DEVICE
K953918 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 25d
Cleared Sep 08, 1995
N 800 HF
K953831 · IZO
Nucletron-Oldelft Corp.
Radiology · 24d
Cleared Sep 06, 1995
KONICA LASER IMAGER LI-21
K950359 · LMC
Storch Amini & Munves PC
Radiology · 222d
Cleared Sep 06, 1995
CHESHIRE
K952778 · LLZ
Perceptive Systems, Inc.
Radiology · 82d
Cleared Sep 06, 1995
CRONEX RADIATION THERAPY CASSETTE
K953724 · IXA
E.I. Dupont DE Nemours & Co., Inc.
Radiology · 27d
Cleared Sep 06, 1995
CRONEX RADIATION THERAPY VERIFICATION CASSETTE
K953725 · IXA
E.I. Dupont DE Nemours & Co., Inc.
Radiology · 27d
Cleared Aug 30, 1995
BONE MINERAL DENSITOMETER
K941362 · KGI
Hologic, Inc.
Radiology · 527d
Cleared Aug 30, 1995
HEALTH IMAGE INC. HI STAR
K944724 · LNH
Health Images, Inc.
Radiology · 339d
Cleared Aug 25, 1995
HEAD IMMOBILIZATION APPARATUS
K941118 · IYE
Northwest Medical Physics Center
Radiology · 536d
Cleared Aug 25, 1995
GAMMACELL 3000 ELAN
K952291 · MOT
Nordion International, Inc.
Radiology · 101d