# K011991: Modification to Medrad Spectris MR Injector

- Pathway: 510(k) (Special)
- Applicant: Medrad, Inc.
- Decided: Aug 21, 2001 after 56 days
- Product code: DXT (Injector And Syringe, Angiographic)
- Device class: 2
- Regulation: 21 CFR 870.1650
- Recalls of this device: none
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Spectris MR Injection System with Communicator ™ is a syringe-based fluid delivery system indicated for delivery of contrast media during Magnetic Resonance Imaging applications. It is intended to be used for the specific purpose of injecting intravenous contrast medium into the human vascular system for diagnostic studies in Magnetic Resonance Imaging. The Communicator connection provides an imaging system interface between the injector and scanner. Only trained healthcare professionals are intended to operate this device.

Source page: https://510kreport.com/device/K011991
Methodology: https://510kreport.com/methodology