# K230393: UniCam Evo Software

- Pathway: 510(k) (Traditional)
- Applicant: Inter Medical Medizintechnik GmbH
- Decided: Apr 13, 2023 after 58 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: 7 generations back to K930090 (1993). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003437: Odyssey LX, Model 211320, Philips Medical Systems (Cleveland), Inc. (2001) Summary page 5.
- K081987: Unisyn Image Fusion, Version 1.0, Convergent Imaging Solutions (2008) Summary page 5.

## Indications for use
The UniCam Evo Software package is indicated for nuclear medicine image post-processing software for scintigraphic and SPECT imaging. UniCam Evo is indicated for processing and quantification of planar and tomographic bone scintigraphy scans, processing of cerebrovascular scintigraphic scans, processing of planar and tomographic cardiovascular scintigraphic studies, renal dynamic scans, planar and SPECT lung scintigraphy, planar gastrointestinal scintigraphic scans, liver scintigraphy, thyroid, parathyroid scintigraphy and displaying multimodal image fusion between SPECT/CT/MR/PET/ultrasound modalities. The UniCam Evo Software is intended for nuclear medicine specialists, nuclear medicine radiologists, or trained medicine technologists. The operator shall have basic computer operation skills. The software loads scintigraphic data sets in Dicom format from the local database or queries the corresponding dicom data from a PACS archive. The operator may perform analysis on the data, ROI analysis, tomographic reconstruction, organ dependent procedure steps and the software displays the results in form of images, numerical data or curves. The operator may print the results, store as an image or dicom secondary capture. Reconstructed transversal, coronal and sagittal slices can be also stored in Dicom 3.0 format.

Source page: https://510kreport.com/device/K230393
Methodology: https://510kreport.com/methodology