FDA 510(k) Regulatory Intelligence Search

Search devices, predicates, manufacturers and submission history used by regulatory affairs and medical device strategy teams.

174,883 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology × Cleared only ×
15,433 results
8401–8424 of 15,433
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jan 20, 2004
MOBILE SINGLE CIRCULAR CAMERA (MSC) & MOBILE DIGITAL CARDIAC CAMERA (MDCC)
K033956 · KPS
Is2 Research, Inc.
Radiology · 29d
Cleared Jan 09, 2004
TRANSVAGINAL ULTRASOUND PROBE HOLDER SYSTEM
K032585 · HDC
Ron-Tech Medical , Ltd.
Radiology · 141d
Cleared Jan 09, 2004
DIAMOND SETUP 2000
K032886 · LHN
K&S Assoc., Inc.
Radiology · 115d
Cleared Jan 09, 2004
ACQSIM-MULTISLICE-CT, MODEL 453567042271
K033357 · JAK
Philips Medical Systems (Cleveland),...
Radiology · 81d
Cleared Jan 09, 2004
FUJI MEDICAL DRY LASER IMAGERS, MODELS DRYPIX 7000, DRYPIX 5000 AND FM-DP L
K033377 · LMC
Fujifilm Medical System U.S.A., Inc.
Radiology · 79d
Cleared Jan 09, 2004
SPIRIT 5000 CARDIAC COIL
K033490 · MOS
Usa Instruments, Inc.
Radiology · 66d
Cleared Jan 08, 2004
HDI 5000 DIAGNOSTIC ULTRASOUND SYSTEM
K034003 · IYN
Philips Ultrasound, Inc.
Radiology · 15d
Cleared Dec 30, 2003
CLEARTOOTH DIGITAL X-RAY SYSTEM
K033147 · MUH
Cleartooth Electronics, Inc.
Radiology · 91d
Cleared Dec 30, 2003
ACUITY WITH CONEBEAM COMPUTED TOMOGRAPHY
K033339 · KPQ
Varian Medical Systems, Inc.
Radiology · 74d
Cleared Dec 30, 2003
MEDICLUNG, RELEASE 1
K033412 · OEB
Medicsight
Radiology · 64d
Cleared Dec 30, 2003
BEBIG ISOSEED I-125
K033781 · KXK
Bebig Isotopen-Und Medizintechnik GmbH
Radiology · 26d
Cleared Dec 30, 2003
MYOLIGHT
K033874 · KPS
Ge Medical Systems F.I. Haifa
Radiology · 15d
Cleared Dec 24, 2003
APEX DETECTOR ELECTRONICS & ACQUISITION INTERFACE, MODEL XL-4
K033001 · KPS
Transphoton Corporation
Radiology · 90d
Cleared Dec 24, 2003
VARIAN INTRACAVITARY BRACHYTHERAPY APPLICATORS
K033371 · JAQ
Varian Medical Systems
Radiology · 64d
Cleared Dec 24, 2003
PORTASCAN BLADDER SCANNER, MODEL PA00146
K033906 · IYO
Mediwatch Plc
Radiology · 7d
Cleared Dec 23, 2003
ERGO SRS
K031281 · MUJ
3D Line USA, Inc.
Radiology · 245d
Cleared Dec 23, 2003
TRILOGY RADIOTHERAPY DELIVERY SYSTEM
K033343 · IYE
Varian Medical Systems, Inc.
Radiology · 67d
Cleared Dec 23, 2003
MODIFICATION TO SECTRA IDS5 RADIOLOGY WORKSTATION - VERSION 10.1
K033712 · LLZ
Sectra-Imtec AB
Radiology · 27d
Cleared Dec 23, 2003
SYNGO PERFUSION-CT
K033832 · JAK
Siemens AG Medical Solutions
Radiology · 13d
Cleared Dec 19, 2003
EXACTRAC GATING
K033287 · IYE
Brainlab AG
Radiology · 66d
Cleared Dec 19, 2003
ALLEGRO IMAGING SYSTEM
K033782 · KPS
Philips Medical Systems (Cleveland),...
Radiology · 15d
Cleared Dec 19, 2003
SIENET COSMOS
K033831 · LLZ
Siemens AG Medical Solutions
Radiology · 9d
Cleared Dec 19, 2003
GE BRAINWAVE OPTION(S) FOR MRI SYSTEMS
K033867 · LNH
General Electric Co.
Radiology · 7d
Cleared Dec 17, 2003
MODIFICATION TO: NUCAMMA RX
K032779 · KPS
Is2 Research, Inc.
Radiology · 100d