FDA.report

510(k) K013999

Device
LODOX, MODEL BASELINE
Applicant
LODOX SYSTEMS (PTY) LTD.
510(k) number
K013999
Product code
JAK  
Decision
Substantially Equivalent (SESE)
Decision date
2002-08-06
Date received
2001-12-04
Regulation
892.1750
Classification name
System, X-ray, Tomography, Computed
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
BRADLEY SACKS
Address
177 E. 79th St. Suite 4 New York NY US 10021 10021

FDA Registration Numbers

Source Documents

510(k) summary PDF

Related GUDID Devices

Primary DIBrandCompanyPublished
06009880828036LODOXLODOX SYSTEMS (PTY) LTD2023-08-31
06009880828166LODOXLODOX SYSTEMS (PTY) LTD2021-08-12
06009880828159LODOXLODOX SYSTEMS (PTY) LTD2021-08-12
06009880828142LODOXLODOX SYSTEMS (PTY) LTD2021-08-12
06009880828111LODOXLODOX SYSTEMS (PTY) LTD2021-08-12
06009880828104LODOXLODOX SYSTEMS (PTY) LTD2021-08-12
06009880828098LODOXLODOX SYSTEMS (PTY) LTD2021-08-12
06009880828081LODOXLODOX SYSTEMS (PTY) LTD2021-08-12
06009880828128LodoxLODOX SYSTEMS (PTY) LTD2019-05-10
06009880828074LodoxLODOX SYSTEMS (PTY) LTD2018-05-02
06009880828067LodoxLODOX SYSTEMS (PTY) LTD2018-04-05

Other 510(k) Records For Product Code JAK  

510(k)DeviceApplicantDecision date
K253596Aquilion ONE (TSX-308A/TSX-306A) V2.0Canon Medical Systems Corporation2026-05-20
K253649Spectral CT Verida FamilyPhilips Medical Systems Technologies , Ltd.2026-03-27
K253686True Definition DLGe Healthcare Japan Corporation2026-03-23
K252992CT Rembra RT; CT Areta RT; CT RembraPhilips Healthcare (Suzhou) Co., Ltd.2026-03-23
K253574SOMATOM X.cite; SOMATOM X.ceedSiemens Medical Solutions USA, Inc.2026-03-20
K253520Photonova Spectra, Photonova Spectra SelectGe Medical Systems, LLC2026-03-20
K260078Aquilion ServeSP (TSX-307B) V2.0Canon Medical Systems Corporation2026-03-13
K252249Extremity CT Imaging SystemMars Bioimaging , Ltd.2026-03-13
K260167Bunkerhill Contrast AVCBunkerHill Health2026-03-06
K260166Bunkerhill Contrast CACBunkerHill Health2026-03-06
K260169AV Cardiac CTPhilips Medical Systems Nederland B.V.2026-03-05
K253173uCT 780 with uWS-CT-Dual Energy AnalysisShanghai United Imaging Healthcare Co., Ltd.2026-01-20
K252217CT VScore+Canon Medical Informatics, Inc.2025-11-28
K251805syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.2025-10-15
K250662Bunkerhill MACBunkerHill Health2025-10-03

Legacy Summary

summary

FDA Review

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