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
11425–11448 of 15,520
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Mar 02, 1995
ACUSON MODEL 3001
K935595 · ITX
Acuson Corp.
Radiology · 468d
Cleared Mar 02, 1995
V5M
K942296 · ITX
Acuson Corp.
Radiology · 294d
Cleared Mar 02, 1995
MEDICAL IMAGE MANAGEMENT SYSTEM (MIM)
K946117 · LLZ
Siemens Medical Solutions Health...
Radiology · 77d
Cleared Mar 02, 1995
DIGITAL SPOT MAMMOGRAPHY FOR STEROTACTIC APPLICATION
K950608 · IZH
Lorad Corp.
Radiology · 21d
Cleared Mar 01, 1995
ULTRASOUND 77030 IMAGING SYSTEM
K944048 · IYN
Hewlett-Packard Co.
Radiology · 195d
Cleared Feb 27, 1995
UNICATH LLU ANGIOGRAPHIC SYSTEM
K945449 · IZI
Xre Corp.
Radiology · 112d
Cleared Feb 24, 1995
FLUOROPLUA CARDIAC AND/OR INSTAVIEW
K941917 · JAA
Fidelity Medical, Inc.
Radiology · 311d
Cleared Feb 24, 1995
AT&T IMAGE SOLUTIONS PICASSO STILL-IMAGE PHONE SYSTEM
K944322 · LMD
At&T Image Solutions
Radiology · 175d
Cleared Feb 24, 1995
MORGANSTERN PROSTATE STABILIZATION AND SEEDING KIT
K944522 · IWJ
Medical Device Technologies, Inc.
Radiology · 161d
Cleared Feb 23, 1995
ULTRA COVER ULTRASOUND TRANSDUCER PROBE COVERS
K921695 · ITX
Parker Laboratories, Inc.
Radiology · 1051d
Cleared Feb 22, 1995
NON-UNIFORM ATTENUATION CORRECTION SYSTEM
K942145 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 295d
Cleared Feb 17, 1995
ANGIOGRAPHIC SYSTEM
K944952 · IZI
Acoma Medical Imaging, Inc.
Radiology · 133d
Cleared Feb 17, 1995
NICOM DIGITAL IMAGE MANAGER
K945654 · LMB
Camtronics, Ltd.
Radiology · 92d
Cleared Feb 16, 1995
FOCUS RTP
K915691 · MUJ
Computerized Medical Systems, Inc.
Radiology · 1151d
Cleared Feb 16, 1995
IORT SYSTEM
K933117 · IYE
Northwest Medical Physics Center
Radiology · 601d
Cleared Feb 15, 1995
MULTILEAF INTENSITY MODULATING COLLIMATOR
K940412 · IXI
Nomos Corp.
Radiology · 384d
Cleared Feb 15, 1995
HIGH DOSE RATE AFTERLOADER
K945383 · JAQ
Varian Assoc., Inc.
Radiology · 113d
Cleared Feb 15, 1995
HFQ HIGH FREQUENCY RADIOGRAPHIC AND FLUROSCOPIC GENERATORS
K945731 · IZO
Bennett X-Ray Corp.
Radiology · 85d
Cleared Feb 15, 1995
BENNETT X-RAY TOMOGRAPHY SYSTEM
K945749 · IZF
Bennett X-Ray Corp.
Radiology · 84d
Cleared Feb 15, 1995
MTS-007, STS-008, SSMTS-010, EURO-40, 72, SUPER EURO 4072, 5000
K946261 · IYB
Scott Imaging Intl., Inc.
Radiology · 64d
Cleared Feb 15, 1995
EURO, SCST, SCCFT ATLAS RADIOLOGIC TABLES
K946262 · IXQ
Scott Imaging Intl., Inc.
Radiology · 64d
Cleared Feb 15, 1995
N 800 HF
K950037 · IZO
Oldelft Corp. of America
Radiology · 42d
Cleared Feb 09, 1995
THE NOMOS CRANE
K941927 · JAI
Nomos Corp.
Radiology · 295d
Cleared Feb 09, 1995
NEOPROBE 1000 PORTABLE RADIOISOTOPE DETECTOR AND ACCESSORIES
K942580 · IZD
Neoprobe Corp.
Radiology · 254d