# K980243: Parameter Developments Dicom Archival Server, (Das)/Dicom Intranet Service (Dis)

- Pathway: 510(k) (Traditional)
- Applicant: Parameter Developments, Inc.
- Decided: Apr 3, 1998 after 70 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: 2 generations back to K921112 (1993). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960326: FCR DMS Optical Disk Image Filing Unit OD-F614, ODF614L & Multimodality System, Fujifilm Medical System U.S.A., Inc. (1996) Summary page 1.
- K960946: Echonet, Lockheed Martin Communications Systems (1996) Summary page 1.
- K960981: Kodak Digital Science (KDS) Medical Image and Information Library, Kodak Health Imaging Systems, Inc. (1996) Summary page 1.
- K961160: Upacs Version 1.7, Base Ten Systems, Inc. (1996) Summary page 1.
- K970064: Amicas Web/Intranet Image Server, Autocyt Group, Inc. (1997) Summary page 1.

## Indications for use
The DICOM Archival Server (DAS)/DICOM IntraNET Service (DIS), software product, provides for the centralized management and storage of radiographic studies, replacing or augmenting the historical film-based processes. The operating environment is provided by Microsoft's @ NT@operating system, Release 4 and later only. This environment provides for all communication (i.e. TCP/IP), file storage (e.g. NTFS), security management and display management processes. It also insulates the DAS/DIS from detail hardware management processes, allowing customers to make whatever choices in-these areas that best serve them.

Source page: https://510kreport.com/device/K980243
Methodology: https://510kreport.com/methodology