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
11977–12000 of 15,520
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
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
Cleared Jul 29, 1993
MULTIVIEW FOR WINDOWS
K931292 · LMD
Image Data Corp.
Radiology · 139d
Cleared Jul 28, 1993
GAMMACON IMAGE TRANSLATION SYSTEM
K931376 · LLZ
Numa Corp.
Radiology · 134d
Cleared Jul 27, 1993
REFIX(TM) SYSTEM
K930279 · IYE
Nomos Corp.
Radiology · 187d
Cleared Jul 27, 1993
GCA-7200A
K931297 · KPS
Toshiba America Medical Systems, In.C
Radiology · 134d
Cleared Jul 27, 1993
NUCLEAR ASSOCIATES MODEL 34-070 BRACHYTHERAPY CAL.
K931657 · KPT
Victoreen, Inc.
Radiology · 113d
Cleared Jul 27, 1993
LCR GENERATOR
K931998 · IZO
Philips Medical Systems (Cleveland),...
Radiology · 95d
Cleared Jul 27, 1993
RADIOACTIVE SAMARIUM 145 SEEDS/SOURCES #2341-2345
K932242 · KXK
Best Industries
Radiology · 81d
Cleared Jul 26, 1993
SPECTURN, MODEL TTK-128
K923180 · IYX
Harpell Assoc., Inc.
Radiology · 391d
Cleared Jul 26, 1993
MODEL #QSC-200-21 20 CM. QUADRATURE SHOULDER COIL
K930045 · LNH
Mri Devices Corp.
Radiology · 202d