# K230294: CoverScan (CoverScan v1.1)

- Pathway: 510(k) (Special)
- Applicant: Perspectum
- Decided: Mar 3, 2023 after 29 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: 15 generations back to K971684 (1997). 64 ancestors in all.
No later device cites it as a predicate yet.
3 of 65 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212565: CoverScan v1, Perspectum, Ltd. (2022) Summary page 4.

## Indications for use
CoverScan is a medical image management and processing software package that allows the display, analysis and post-processing of DICOM compliant medical images and MR data. CoverScan provides both viewing and analysis capabilities to ascertain quantified metrics of multiple organs such as the heart, lungs, liver, spleen, pancreas and kidney. CoverScan provides measurements in different organs to be used for the assessment of longitudinal and transversal relaxation time (T1, srT1, cT1, T2), fat content (proton density fat fraction or PDFF) and metrics of organ function (e.g., left ventricular ejection fraction and lung fractional area change on deep inspiration). These metrics derived from the images, when interpreted by a licensed physician, yield information that may assist in diagnosis, clinical management and monitoring of patients. CoverScan is not intended for asymptomatic screening. This device is intended for use with Siemens 1.5T and Siemens 3T MRI scanners.

Source page: https://510kreport.com/device/K230294
Methodology: https://510kreport.com/methodology