FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology ×
15,620 results
9553–9576 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Feb 07, 2001
ULTRASOUND SCANNER TYPE 2101
K003041 · IYO
B & K Medical A/S
Radiology · 131d
Cleared Feb 02, 2001
P3IMRT TM
K002237 · MUJ
Adac Laboratories
Radiology · 193d
Cleared Feb 02, 2001
SELECT SEED I-125
K002429 · KXK
Nucletron Corp.
Radiology · 178d
Cleared Feb 02, 2001
SURGI-VISION GUIDEWIRE COIL
K003436 · MOS
Surgi-Vision, Inc.
Radiology · 88d
Cleared Feb 02, 2001
ODYSSEY LX, MODEL 211320
K003437 · LLZ
Philips Medical Systems (Cleveland),...
Radiology · 88d
Cleared Feb 02, 2001
PORTALVISION
K003636 · IYE
Varian Medical Systems, Inc.
Radiology · 70d
Cleared Feb 02, 2001
PHS-63 PEDIATRIC HEAD AND SPINE ARRAY COIL
K003655 · MOS
Mri Devices Corp.
Radiology · 67d
Cleared Feb 02, 2001
OPDIMA
K003945 · IZH
Siemens Medical Solutions USA, Inc.
Radiology · 43d
Cleared Feb 02, 2001
X-RAY SYSTEM XR-MX
K004037 · JAA
Karl Storz Endoscopy
Radiology · 36d
Cleared Feb 02, 2001
MODIFICATION TO ARTOSCAN M
K010057 · LNH
Biosound Esaote, Inc.
Radiology · 25d
Cleared Jan 30, 2001
CT PERFUSION 2
K010042 · JAK
General Electric Co.
Radiology · 25d
Cleared Jan 23, 2001
DIFFUSION TENSOR IMAGING OPTION
K003573 · LNH
Ge Medical Systems, Inc.
Radiology · 64d
Cleared Jan 23, 2001
MAGNETOM RHAPSODY SYSTEM
K003628 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 60d
Cleared Jan 23, 2001
VITREA 2 CT PERFUSION OPTION
K003639 · JAK
Vital Images, Inc.
Radiology · 60d
Cleared Jan 22, 2001
PHILIPS EASY VISION FAMILY WORKSTATION OPTION MR QUANTITATIVE FLOW
K003459 · LLZ
Philips Medical Systems North...
Radiology · 76d
Cleared Jan 22, 2001
VIEW READING STATION
K003688 · LLZ
Electromed Intl., Ltd.
Radiology · 53d
Cleared Jan 19, 2001
QPS (QUANTITATIVE PERFUSION SPECT), QGS (QUANTITATIVE GATED SPECT)
K003358 · KPS
Smv America
Radiology · 85d
Cleared Jan 19, 2001
CODONICS NP-1660 SERIES MEDICAL PRINTERS, MODEL 1660
K003481 · LMC
Codonics, Inc.
Radiology · 71d
Cleared Jan 19, 2001
NETRA WORKSTATION AND NETRAMD SOFTWARE
K003484 · LLZ
Scimage, Inc.
Radiology · 71d
Cleared Jan 18, 2001
ACTIVE ARRAY CATHETER, MODEL CS-2000
K001097 · MOS
Image-Guided Neurologics, Inc.
Radiology · 289d
Cleared Jan 18, 2001
SYMPULSE COMPUTER SYSTEM FOR FONAR MRI SCANNERS
K003453 · LNH
Fonar Corp.
Radiology · 72d
Cleared Jan 18, 2001
U-SYSTEMS ULTRASOUND SYSTEM USI-2000
K003479 · IYN
U-Systems, Inc.
Radiology · 70d
Cleared Jan 18, 2001
MRI LINE MARKER
K003736 · JAK
I.Z.I. Corp.
Radiology · 45d
Cleared Jan 18, 2001
VIVID 7 WITH SONOPAC, MODEL FB0008XX
K003931 · IYN
Ge Medical Systems, Inc.
Radiology · 29d