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
13393–13416 of 15,520
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jun 01, 1989
VERSION 4.2 APPLICATION SOFTWARE
K892959 · LNH
Resonex, Inc.
Radiology · 38d
Cleared Jun 01, 1989
CXC FFT-1 NON-TILT STAT RADIO XRAY TAB 4 WA FL TAB
K893129 · IZZ
Continental X-Ray Corp.
Radiology · 37d
Cleared May 31, 1989
OPTIONAL PROBE OF CANON IOL ESTIMATOR KU-1
K891225 · IYO
Canon USA, Inc.
Radiology · 85d
Cleared May 26, 1989
ANGIOTEC ZX DIGITAL IMAGE PROCESSOR
K892869 · LLZ
Andros Analyzers, Inc.
Radiology · 37d
Cleared May 22, 1989
ND1100 BONE DENSITY SCANNER
K881383 · KGI
Nuclear Data, Inc.
Radiology · 416d
Cleared May 22, 1989
MULTI PULSE POWER UNIT GENERATOR
K892943 · IZO
GE Medical Systems
Radiology · 31d
Cleared May 18, 1989
SCOPIX LASER IMAGER
K891924 · LMC
Enhanced Imaging Technologies, Inc.
Radiology · 52d
Cleared May 18, 1989
QCT-LUNG NODULE (TM) ANALYSIS PACKAGE
K891931 · JAK
Image Analysis, Inc.
Radiology · 51d
Cleared May 16, 1989
ACUSON S228 TRANSDUCER FOR TRANSCRANIAL DOPPLER
K890055 · IYN
Acuson Corp.
Radiology · 130d
Cleared May 16, 1989
TRANSESOPHAGEAL TRANSDUCER PEF-511SA
K890969 · IYO
Toshiba Medical Systems
Radiology · 78d
Cleared May 16, 1989
5.0 MHZ ARRAY INTRAVAGINAL TRANSDUCER
K891309 · IYO
Advanced Technology Laboratories, Inc.
Radiology · 67d
Cleared May 16, 1989
CVIS ULTRA-SCAN ONE IMAGING SYSTEM
K891386 · IYO
Cardiovascular Imaging Systems, Inc.
Radiology · 68d
Cleared May 11, 1989
PHILIPS DIGITAL CARDIAC IMAGING (DCI) SYSTEM
K885327 · LMB
Philips Medical Systems North...
Radiology · 134d
Cleared May 11, 1989
TRUVEL TZ-3X X-RAY DIGITIZING SCANNER
K890970 · LMA
Truvel Corp.
Radiology · 73d
Cleared May 11, 1989
MAGNETIC RESONANCE DEVICE ACCESSORY SOFTWARE 4.0.
K891541 · LNH
Diasonics, Inc.
Radiology · 55d
Cleared May 11, 1989
MODEL 2030
K891598 · LNH
Medical Advances, Inc.
Radiology · 52d
Cleared May 11, 1989
GE SHOULDER SURFACE COIL, CAT. #M1085AN
K892235 · LNH
General Electric Co.
Radiology · 37d
Cleared May 10, 1989
ULTRASONIC IMAGING CATHETER FOR CARDIAC APPLI.
K890772 · IYO
Boston Scientific Corp
Radiology · 84d
Cleared May 05, 1989
STEREOTACTIC BIOPSY ATTACHMENT
K884107 · IZH
Siemens Medical Solutions USA, Inc.
Radiology · 218d
Cleared May 05, 1989
ANGIOTEC FMX-2220 SYSTEM
K891485 · LMB
Andros Analyzers, Inc.
Radiology · 49d
Cleared May 03, 1989
LABSONICS MAMM-O-MATE MODEL NO. 918084-1
K890519 · IYO
Laboratory Equipment Corp.
Radiology · 90d
Cleared May 03, 1989
MAMMOMAT C
K890784 · IZH
Siemens Medical Solutions USA, Inc.
Radiology · 77d
Cleared May 03, 1989
GENERAL ELECTRIC AMX 110
K891143 · IZL
Pro-Tronics, Inc.
Radiology · 61d
Cleared May 02, 1989
QAD ANGIODYNOGRAPH ULTRASOUND: COLOR DOPPLER EVAL.
K890998 · IYN
Quantum Medical Systems, Inc.
Radiology · 88d