# K984088: Optistar MR Injector System

- Pathway: 510(k) (Traditional)
- Applicant: Mallinckrodt Inc., Liebel-Flarsheim Business
- Decided: Dec 6, 1999 after 385 days
- Product code: DXT (Injector And Syringe, Angiographic)
- Device class: 2
- Regulation: 21 CFR 870.1650
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K935668 (1995). 1 ancestor in all.
22 later devices descend from it; 5 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K935668: Medrad Spectris MR Injector, Medrad, Inc. (1995) Summary page 1.

## Most influential descendants
- K051799: Disposable CT/MR Syringes for Nemoto Injectors (2005), 18 descendants of its own
- K072696: Ant Angiographic Syringes, Model (S) 100101,102,103,100201,202,203,204,100301,200101,201,202, 203,200301,101,102,202,301 (2008), 15 descendants of its own
- K151960: Sterile High-pressure Angiographic Syringes for Single-use (2016), 8 descendants of its own
- K192657: Sterile High-pressure Angiographic Syringes for Single-use (2020), 4 descendants of its own
- K211564: Sterile High-pressure Angiographic Syringes for Single-use (2021), 2 descendants of its own

## Recalls of this device
- Feb 10, 2012 · Not classified · Z-1121-2012: The machine used to package the product was missing a tool, which could prevent the packaging from sealing properly, causing the sterility of the product to be compromised.
- Feb 10, 2012 · Not classified · Z-1120-2012: The machine used to package the product was missing a tool, which could prevent the packaging from sealing properly, causing the sterility of the product to be compromised.
- Feb 10, 2012 · Not classified · Z-1122-2012: The machine used to package the product was missing a tool, which could prevent the packaging from sealing properly, causing the sterility of the product to be compromised.
- Feb 10, 2012 · Not classified · Z-1118-2012: The machine used to package the product was missing a tool, which could prevent the packaging from sealing properly, causing the sterility of the product to be compromised.
- Feb 10, 2012 · Not classified · Z-1119-2012: The machine used to package the product was missing a tool, which could prevent the packaging from sealing properly, causing the sterility of the product to be compromised.

## Indications for use
The Optistar MR is designed to inject MR contrast agents and flushing solutions for the purpose of enhancing diagnostic imaging of humans. Contraindications for the use of this device are determined by the prescribing physician at the time of use based upon the contrast media package inserts. Not to be used in a magnetic field greater than 1.5 Tesla.

Source page: https://510kreport.com/device/K984088
Methodology: https://510kreport.com/methodology