# K212984: MiPACS HTML5 Web Viewer

- Pathway: 510(k) (Traditional)
- Applicant: Lead Technologies, Inc.
- Decided: Nov 12, 2021 after 56 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: 1 generation back to K182572 (2019). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182572: InstaRISPACS / InstaZFP / InstaMobi v5.0, Meddiff Technologies Pvt., Ltd. (2019) Summary page 4.

## Most influential descendants
- K260231: MiPACS V5 (1.0.0) (2026), 0 descendants of its own

## Indications for use
MiPACS HTMLS Web Viewer, is a software device, that enables Users to view and manipulate medical images. Patient images/studies can be accessed by Users locally within the system or across a wide-area network at distributed locations. The MiPACS HTMLS5 Web Viewer requires no installation on the client’s behalf and is compatible with any HTML5-compliant web browser (e.g. Google Chrome, Microsoft Internet Explorer 10, Microsoft Edge, Mozilla Firefox, MacOS). Only preprocessed DICOM for presentation images can be interpreted for primary image diagnosis in mammography. Mammographic images with lossy, compression and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA cleared display that meets technical specifications reviewed and accepted by FDA. MiPACS HTMLS5 Web Viewer, is not intended for diagnostic image review on mobile devices.

Source page: https://510kreport.com/device/K212984
Methodology: https://510kreport.com/methodology