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
10465–10488 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Feb 25, 1998
ECHOLINK
K980060 · LLZ
Mpacs, LLC
Radiology · 49d
Cleared Feb 24, 1998
DYNEMO 3000
K972798 · DPW
Sometec, Inc.
Radiology · 211d
Cleared Feb 24, 1998
PEGASYS INTOUCH
K974474 · LLZ
Adac Laboratories
Radiology · 90d
Cleared Feb 20, 1998
ANATOM 1000 (A MINUS, A-)
K974455 · JAK
Analogic Corp.
Radiology · 87d
Cleared Feb 17, 1998
REGANES RADIONUCLIDE SEED MAGAZINE
K972554 · IWJ
Avid N.I.T., Inc.
Radiology · 224d
Cleared Feb 17, 1998
INTERVENTIONAL MOBILE DIGITAL IMAGING SYSTEM (HEREIN CALLED IMDIS)
K974355 · OWB
Ge Dec Medical Systems
Radiology · 90d
Cleared Feb 13, 1998
NORLAND BODY COMPOSITION OPTION FOR NORLAND DEXA BONE DENSITOMETERS
K973459 · KGI
Norland Corp.
Radiology · 154d
Cleared Feb 13, 1998
RTR-2000/RTR-4000
K974307 · JAK
Terarecon,Inc.
Radiology · 88d
Cleared Feb 13, 1998
ADVANTX LCN, ADVANTX LCLP
K974367 · IZI
GE Medical Systems
Radiology · 85d
Cleared Feb 13, 1998
EXPERT-XL LATERAL SPINE BMD ACQUISITION AND ANALYSIS SOFTWARE
K974437 · KGI
Lunar Corp.
Radiology · 81d
Cleared Feb 13, 1998
NUMASTATION
K974444 · KPS
Numa, Inc.
Radiology · 80d
Cleared Feb 13, 1998
IISYS PACS SYSTEM
K980220 · LMD
Sterling Diagnostic Imaging, Inc.
Radiology · 22d
Cleared Feb 11, 1998
PHASED ARRAY TRANSDUCER - - PVF -375DT
K972771 · ITX
Toshiba America Medical Systems, In.C
Radiology · 202d
Cleared Feb 10, 1998
AKTINA MEDICAL PHYSICS CORPORATION PHOTON BEAM BLOCKING SYSTEM
K974239 · IXI
Aktina Medical Physics Corp.
Radiology · 90d
Cleared Feb 09, 1998
AIRIS II
K974212 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 91d
Cleared Feb 09, 1998
ULTRAGUIDE 1000
K974432 · IYO
Ultraguide , Ltd.
Radiology · 77d
Cleared Feb 06, 1998
CLK INT'L. SANITARY LATEX PROBE COVER, CLK ULTRASOUND PROBE COVER
K974301 · ITX
Clk Intl., Inc.
Radiology · 81d
Cleared Feb 06, 1998
NOMOS SLIT COLLIMATOR (BEAK)
K974310 · IYE
Nomos Corp.
Radiology · 81d
Cleared Feb 06, 1998
DUFFUSION-WEIGHTED MR IMAGING PACKAGE
K974530 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 66d
Cleared Feb 05, 1998
MAGNETIC RESONANCE DIAGNOSTIC SYSTEM
K972990 · LNH
GE Medical Systems
Radiology · 177d
Cleared Feb 05, 1998
IMEX STETHODOP
K973336 · JAF
Imex Medical Systems, Inc.
Radiology · 154d
Cleared Jan 30, 1998
PHILIPS EASYVISION
K971965 · LLZ
Philips Medical Systems, Inc.
Radiology · 247d
Cleared Jan 29, 1998
NORLAND MODEL PDEXA BONE DENSITOMETER
K973104 · KGI
Norland Corp.
Radiology · 163d
Cleared Jan 29, 1998
VACUDAP, MODEL 2000, 2001
K974112 · KPR
Victoreen, Inc.
Radiology · 90d