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
13705–13728 of 15,520
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Apr 18, 1988
THE ESI-2000 ULTRASOUND UNIT
K874683 · IYO
Elscint, Inc.
Radiology · 152d
Cleared Apr 15, 1988
TRANS/R NEEDLE GUIDE
K875128 · IYO
CIVCO Medical Instruments Co., Inc.
Radiology · 122d
Cleared Apr 15, 1988
TRANS/P NEEDLE GUIDE
K875236 · IYO
CIVCO Medical Instruments Co., Inc.
Radiology · 115d
Cleared Apr 15, 1988
TRANS/V NEEDLE GUIDE
K875240 · IYO
CIVCO Medical Instruments Co., Inc.
Radiology · 115d
Cleared Apr 14, 1988
CIVCO SEED IMPLANT NEEDLE GUIDE
K875241 · IYO
CIVCO Medical Instruments Co., Inc.
Radiology · 114d
Cleared Apr 14, 1988
TEKNAR PROSCAN ACCESSORY PROBE
K880659 · IYO
Teknar, Inc.
Radiology · 57d
Cleared Apr 12, 1988
KODAK AUTOMATIC FILM FEEDER, MODEL 11
K881248 · IXW
Eastman Kodak Company
Radiology · 20d
Cleared Apr 11, 1988
VENTI-SCAN II
K871868 · IYT
Atomic Products Corp.
Radiology · 334d
Cleared Apr 11, 1988
HUESTIS COMPU-FORMER
K880047 · IXI
Huestis Machine Corp.
Radiology · 96d
Cleared Apr 07, 1988
SIM 4000I
K873845 · IYO
Ote-Biomedica Elettronica S.P.A
Radiology · 198d
Cleared Mar 31, 1988
AXIAL TOME, 60, FLUORO AND TOMAX
K872825 · EHD
Axialtome Corp.
Radiology · 259d
Cleared Mar 31, 1988
TRANSRECTAL PROBE BD65S-TR
K880219 · IYO
Elscint, Inc.
Radiology · 71d
Cleared Mar 28, 1988
SINGLE PHASE DIAGNOSTIC X-RAY GENERATOR FX 350
K880532 · IZO
Fischer Imaging Corp.
Radiology · 48d
Cleared Mar 28, 1988
PICS-2000
K880822 · JAK
Philips Medical Systems, Inc.
Radiology · 27d
Cleared Mar 28, 1988
SOMATOM PLUS
K880965 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 20d
Cleared Mar 23, 1988
SDR 3500 (PHILIPS PLATINUM +)
K873937 · IYO
Philips Ultrasound, Inc.
Radiology · 177d
Cleared Mar 21, 1988
3M XP515 X-RAY FILM PROCESSOR
K880563 · IXW
3M Company
Radiology · 40d
Cleared Mar 21, 1988
3M XP 505 X-RAY FILM PROCESSOR
K880564 · IXW
3M Company
Radiology · 40d
Cleared Mar 21, 1988
3M TRIMATIC M MODULAR SYSTEM AND ACCESSORIES
K880565 · IXW
3M Company
Radiology · 40d
Cleared Mar 21, 1988
MAMMOGRAPHY MOVING GRID BUCKY
K880905 · IZH
Custom Medical Products, Ltd.
Radiology · 19d
Cleared Mar 15, 1988
NIDEK UP-2000
K880065 · IYO
Nidek, Inc.
Radiology · 68d
Cleared Mar 15, 1988
VISION CARE/PHAKOSYSTEMS ECHOPACH
K880081 · IYO
Phakosystems, Inc.
Radiology · 64d
Cleared Mar 09, 1988
CEMAX 5000 MULTIDIMENSIONAL IMAGING WORKSTATION
K880169 · LLZ
Cemax, Inc.
Radiology · 54d
Cleared Mar 09, 1988
MOBILE C-ARM OMNI 325
K880518 · OXO
Fischer Imaging Corp.
Radiology · 29d