# K060840: SVIEW

- Pathway: 510(k) (Traditional)
- Applicant: Mri Cardiac Services, Incorporated
- Decided: Apr 7, 2006 after 10 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K945188 (1995). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990241: Accuimage, Accuview Diagnostic Imaging, Workstation W/Accuscore, Accuanalyze, Accuscope, Accushade, Accuvrt, and Accumip, Accuimage Diagnostics Corp. (1999) Summary page 1.

## Indications for use
SView TM 1.0 is a medical image management device intended for viewing, manipulating and analyzing DICOM-compliant medical images acquired from MRI scanners and other DICOM-compliant imaging devices. SView TM 1.0 can be used for real-time image viewing, manipulation and analysis that aid a cardiologist or radiologist in their diagnosis. In addition, it facilitates the physician's reporting and reviewing of patient studies.

Source page: https://510kreport.com/device/K060840
Methodology: https://510kreport.com/methodology