# K963936: Accesspoint, Med E-Mail, Dicom Reader

- Pathway: 510(k) (Traditional)
- Applicant: Biosound, Inc.
- Decided: Mar 31, 1997 after 181 days
- Product code: LMB (Device, Digital Image Storage, Radiological)
- Device class: 1
- Regulation: 21 CFR 892.2010
- 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 K950279 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K950279: TOMTECP90, Tomtec Imaging Systems, Inc. (1995) Summary page 2.

## Indications for use
The AccessPoint™ software is intended to translate different medical image formats into a single format suitable for display on a standard Personal Computer.

Source page: https://510kreport.com/device/K963936
Methodology: https://510kreport.com/methodology