# K080297: Medrad Intego Pet Infusion System

- Pathway: 510(k) (Traditional)
- Applicant: Medrad, Inc.
- Decided: Jun 17, 2008 after 134 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K021988 (2002). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032771: Medrad Continuum MR Infusion System, Medrad, Inc. (2003) Summary page 1.
- K030066: Cal/Rad Mark VI/VDC-505 Dose Calibrator, Model 34-165, Nuclear Associates (2003) Summary page 1.
- K050456: Medrad Avanta Fluid Management Injection System, Medrad, Inc. (2005) Summary page 1.
- (no number) Personnel Protective Shield: named in the summary without a submission number
- (no number) Radionuclide Rebreather System: named in the summary without a submission number

## Recalls of this device
- Sep 30, 2016 · Class II · Z-0400-2017: The Source Administration Sets (SAS) used with the Medrad Intego PET Infusion System do not meet pressure testing specifications in an occlusion situation when the product is more than one year past m

## Indications for use
The MEDRAD Intego PET Infusion System is intended to deliver accurate doses of 18F Fluorodeoxyglucose (FDG) radiopharmaceuticals and commonly used flushing solutions to patients during molecular imaging (nuclear medicine) diagnostic procedures. The MEDRAD Intego PET Infusion System is also intended to provide effective radiation shielding to medical personnel from Fluorine-18 (18F) radiation exposure during nuclear medicine diagnostic procedures.

Source page: https://510kreport.com/device/K080297
Methodology: https://510kreport.com/methodology