# K100798: Medrad Intego Pet Infusion System, Source Administration Set, Patient Adminstratin Set Model Int Sys 100, Int CSS, Int C

- Pathway: 510(k) (Traditional)
- Applicant: Medrad, Inc.
- Decided: Jun 23, 2010 after 93 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) MEDRAD Intego™ PET Infusion System: named in the summary without a submission number

## Recalls of this device
- Nov 30, 2022 · Class II · Z-0910-2023: Black specks may be present on the packaged needles
- 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
- Nov 30, 2015 · Class II · Z-0627-2016: The firm's investigation of the Medrad Intego indicates that the inner diameter of the saline tubing is out of specification and may result in the system failing to position the dose correctly during 

## Indications for use
The MEDRAD Intego T M PET Infusion System for '8 F Fluorodeoxyglucose (EDG) or 18 Sodium Fluoride (NaF) is intended to deliver accurate doses of 18F Fluorodeoxyglucose (EDG) or 18F Sodium Fluoride (NaF) radiopharmaceuticals and commonly used flushing solutions to patients during molecular imaging (nuclear medicine) diagnostic procedures. The MEDRAD lntego T M PET Infusion System is also intended to provide effective radiation shielding to medical personnel from Fluorine-IS8 ('8 F) radiation exposure during nuclear nmedicine diagnostic procedures.

Source page: https://510kreport.com/device/K100798
Methodology: https://510kreport.com/methodology