# K221984: InterView XP; InterView FUSION

- Pathway: 510(k) (Traditional)
- Applicant: Mediso Medical Imaging Systems, Lttd.
- Decided: Mar 29, 2023 after 266 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: 11 generations back to K010641 (2001). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201103: Xeleris V Processing and Review Systems, GE Healthcare (2020) Summary page 6.

## Indications for use
InterView XP is a Software as Medical Device (SaMD) aimed at reviewing medical images such as planar scans (Static, Whole Body, Dynamic, Multi-Gated) and tomographic scans (SPECT, Gated SPECT) acquired by gamma cameras. Review of other image modalities is also supported. Common Users for clinical purposes are trained medical professionals, including clinicians and technicians in hospitals or imaging centers. Software components provide functions for image display, manipulation, enhancements, analysis and quantification. This device is not indicated for mammography use or dental diagnostics. The software provides diagnostic information, however, diagnostic decision cannot be based solely on the software. InterView XP has no specific target population. InterView FUSION is a Software as Medical Device (SaMD) aimed at reviewing medical im- ages such as planar scans and tomographic scans from SPECT, PET, CT, and MRI modalities. Review of other image modalities is also supported. The common users for clinical purposes are trained medical professionals, including clinicians and technicians in hospitals or imaging centers. Software components provide functions for image display, manipulation, enhancements, analysis, and quantification. This device is not indicated for mammography use or dental diagnostics. The software provides diagnostic information — however, diagnostic decisions cannot be based solely on this software. InterView FUSION has no specific target population.

Source page: https://510kreport.com/device/K221984
Methodology: https://510kreport.com/methodology