# K971347: Medisurf

- Pathway: 510(k) (Traditional)
- Applicant: International Regulatory Consultants
- Decided: Jul 3, 1997 after 84 days
- Product code: LMD (System, Digital Image Communications, Radiological)
- Device class: 1
- Regulation: 21 CFR 892.2020
- 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 K954678 (1996). 1 ancestor in all.
6 later devices descend from it; 5 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954678: Pro Vision, Algotec Systems, Ltd. (1996) Summary page 1.

## Most influential descendants
- K982769: Mitra Imaging Inc. Exhibit (1998), 1 descendant of its own
- K981053: Kodak Digital Sciences (KDS) Image View (1998), 1 descendant of its own
- K031473: Rational Imaging Pacs (2003), 0 descendants of its own
- K992698: Stentor, Pageview (1999), 0 descendants of its own
- K984405: Echolive Family, Models: ZL-1010,ZL-2000,ZL-2100,ZL-3000,ZL-4000 (1999), 0 descendants of its own

## Indications for use
MediSurf is intended to facilitate access to clinical images and information in distributed locations. Along with image processing capabilities, MediSurf can be used by radiologists for on-call teleradiology over “intranets”, Internet, direct or dial-up lines, and for providing second opinion services. It can also be used by physicians for enhanced interpretation of cases through the inclusion of images in imaging related reports and in patient records in general. Similarly it can be used by healthcare organization staff for facilitated access to clinical images throughout the healthcare organization.

Source page: https://510kreport.com/device/K971347
Methodology: https://510kreport.com/methodology