System, Rebreathing, Radionuclide
Radiology · 21 CFR 892.1390
Recent MDR events
11 adverse event reports on file
- INSTA/VENTOct 6, 2025MalfunctionMedi Nuclear Corp., Inc.MW5176971
- INSTA/VENTOct 6, 2025MalfunctionMedi Nuclear Corp, Inc.MW5176972
- AERO/VENT JR.Jun 7, 2023Injury2050098-2023-00001
- AERO/VENT JR.May 15, 2023MalfunctionMedi/nuclear Corporation, Inc.16929910
- Unnamed deviceFeb 28, 2021Malfunction3012307300-2021-01636
- XENON PULMONEX IIJul 3, 2013OtherBiodex Medical Systems, Inc.2431314-2013-00001
- XENON PULMONEX IIMay 15, 2013Biodex Medical Systems Inc.3124895
- VENTSCAN IV DISPOSABLEJul 17, 2012MalfunctionBiodex2689202
- RAD SOURCE/RS 3000Jun 6, 2002Malfunction*1063922-2002-00001
- Unnamed deviceOct 21, 1998Other2431314-1998-00001
Event type breakdown
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
13 firms currently registered for this product code
King Systems Corporation.
Noblesville, IN, US
Curium Us Llc
Maryland Heights, MO, US
Sunmed Group Holdings, Llc
Grand Rapids, MI, US
Mallinckrodt Hospital Products, Inc.
Hazelwood, MO, US
Medi Nuclear Corp., Inc.
BALDWIN PARK, CA, US
Ups Supply Chain Solutions, Inc.
Louisville, KY, US
Mirion Technologies (capintec), Inc
Florham Park, NJ, US
Productos Urologos De Mexico S.a. De C.v.
MEXICALI Baja California, MX
Tricor Systems
ELGIN, IL, US
Mallinckrodt Manufacturing Llc
MADISON, WI, US
Radnostix
IDAHO FALLS, ID, US
Cyclomedica Australia Pty Ltd
Kingsgrove New South Wales, AU
510(k) clearances
49 clearances for this product code
- Mirion Technologies (Capintec), Inc.Jul 7, 2026
K253942 · Pulmonex II Xenon System (132-503)
- Cyclomedica Australia Pty, Ltd.Sep 1, 2020
K200916 · Patient Administration Set
- King Systems Corp.Nov 3, 1995
K953513 · XENON CIRCUIT
- Intertech Resources, Inc.Aug 11, 1995
K952223 · XENON GAS BREATHING CIRCUIT
- Gibeck, Inc.Feb 27, 1992
K914747 · XENON CIRCUIT
- Tetley Medical , Ltd.Oct 28, 1991
K913416 · TETLEY PATIENT ADMINISTRATION SET
- Vital Signs, Inc.Aug 2, 1991
K912626 · BOLUS XENON CIRCUIT
- Amici, Inc.Jan 14, 1991
K904684 · AMICI KRYPTON ADMINISTRATION SYSTEM, MODIFICATION