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510(k) K253942

Device
Pulmonex II Xenon System (132-503)
Applicant
Mirion Technologies (Capintec), Inc.
510(k) number
K253942
Product code
IYT
Decision
Substantially Equivalent (SESE)
Decision date
2026-07-07
Date received
2025-12-09
Regulation
892.1390
Classification name
System, Rebreathing, Radionuclide
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
Y

Applicant Contact#

Contact
Mary Anne Yusko
Address
7 Vreeland Rd. Florham Park NJ US 07932 07932

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code IYT#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K200916Patient Administration SetCyclomedica Australia Pty, Ltd.2020-09-01
K953513XENON CIRCUITKing Systems Corp.1995-11-03
K952223XENON GAS BREATHING CIRCUITIntertech Resources, Inc.1995-08-11
K914747XENON CIRCUITGibeck, Inc.1992-02-27
K913416TETLEY PATIENT ADMINISTRATION SETTetley Medical , Ltd.1991-10-28
K912626BOLUS XENON CIRCUITVital Signs, Inc.1991-08-02
K903805AMICI XENON ADMINISTRATION SETAmici, Inc.1991-01-14
K904684AMICI KRYPTON ADMINISTRATION SYSTEM, MODIFICATIONAmici, Inc.1991-01-14
K903694AMICI TRU-FIT SOFT PLASTIC MOUTHPIECEAmici, Inc.1990-10-03
K896885DISPOSABLE RESPIRTORY KIT (MP-200)Medipart Jerry Alexander1990-02-26
K896125MEDIPART DISPOSABLE XENON-133 REBREATHING MP-0133MMedipart Jerry Alexander1990-02-01
K896124MEDIPART DISPOSABLE XENON-133 REBREATHING MP-0133Medipart Jerry Alexander1990-01-22
K896475DISP. RADIOAEROSOL KIT (MP-400) TO FIT LEAD SHIELDMedipart Jerry Alexander1990-01-22
K896476DISP. RADIOAEROSOL KIT (MP-400-M) TO FIT SHIELDMedipart Jerry Alexander1990-01-22
K881812AERO-MIST NEBULIZERCadema Medical Products, Inc.1988-07-18