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
11881–11904 of 15,433
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Sep 07, 1993
POYDOROS LX
K931930 · IZO
Siemens Medical Solutions USA, Inc.
Radiology · 144d
Cleared Sep 07, 1993
THYROID UPTAKE SYSTEM & ATOMLAB 950 MED. SPECTROME
K932153 · IZD
Biodan Medical Systems, Ltd.
Radiology · 126d
Cleared Sep 07, 1993
MAG RESON DIAG DEVI ACCESS CIR POLAR(CP) HEAD COIL
K932374 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 113d
Cleared Sep 07, 1993
MAG RES DIAG DEV ACCESS CIR POL(CP) BODY/SPINE COI
K932375 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 113d
Cleared Sep 07, 1993
SIRESKOP CX
K932445 · JAA
Siemens Medical Solutions USA, Inc.
Radiology · 110d
Cleared Sep 07, 1993
POLYDOROS IS
K933240 · IZO
Siemens Medical Solutions USA, Inc.
Radiology · 67d
Cleared Aug 30, 1993
FUKUDA DENSHI MODEL UF-4500
K922208 · IYO
Fukuda Denshi USA, Inc.
Radiology · 475d
Cleared Aug 30, 1993
MAGNETOM P8
K932338 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 108d
Cleared Aug 26, 1993
PRO-FLO SYSTEM
K931896 · FCE
Lafayette Pharmacal, Inc.
Radiology · 133d
Cleared Aug 26, 1993
AUTOTUNE DEVICE (ATD II) FOR PICKER MRI SYSTEMS
K932292 · LNH
Medrad, Inc.
Radiology · 108d
Cleared Aug 23, 1993
AVIVA F22/MAM-CH22 W/OPTIONAL CYTOGUIDE BIOPSY SYS
K930282 · IZH
Elscint, Inc.
Radiology · 214d
Cleared Aug 23, 1993
SPECTRUM MARK I SPECIAL PROCEDURES TABLE
K931563 · IXR
Spectrum X-Ray Corp.
Radiology · 146d
Cleared Aug 23, 1993
2000 X-RAY - TOMOGRAPHIC
K931815 · IZF
Imaging Sciences Intl., Inc.
Radiology · 137d
Cleared Aug 23, 1993
MAMMO-300 AUTOMATIC X-RAY FILM PROCESSOR
K931882 · IXW
Alphatek Corp.
Radiology · 131d
Cleared Aug 23, 1993
AX-390SE AUTOMATIC X-RAY FILM PROCESSOR 9586.033
K931883 · IXW
Alphatek Corp.
Radiology · 131d
Cleared Aug 23, 1993
STENOSCOP MOBILE FLUOROSCOPIC XRAY SYSTEM
K933447 · OXO
GE Medical Systems
Radiology · 41d
Cleared Aug 18, 1993
LINAC-BASED STEROTACTIC RADIOSURGERY
K923522 · IYE
Radionics Software Applications, Inc.
Radiology · 398d
Cleared Aug 16, 1993
ENDOSCOPIC ULTRASOUND SYSTEM TYPE 20
K926514 · ODG
Olympus Corp.
Radiology · 229d
Cleared Aug 16, 1993
SUPERSTAND 3000
K933253 · IYB
Wuestec Medical, Inc.
Radiology · 45d
Cleared Aug 16, 1993
FUJI DAYLIGHT CASSETTE MULTI-LOADER
K933408 · IXW
Fujifilm Medical System U.S.A., Inc.
Radiology · 35d
Cleared Aug 09, 1993
M6-M
K930699 · IZL
X-Cel X-Ray Corp.
Radiology · 180d
Cleared Aug 05, 1993
C-EQUAL(CEDERS-EMORY QUANTITIVE ANALYSIS)
K932745 · KPS
Adac Laboratories
Radiology · 58d
Cleared Aug 05, 1993
QUANTEM (TM)
K932957 · IYX
GE Medical Systems
Radiology · 49d
Cleared Aug 03, 1993
9150A, 1100F
K932355 · IZL
Dynarad Corp.
Radiology · 82d