510(k) Report

510(k) · Cleared

Cleared

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

K980243510(k) TraditionalCleared Apr 3, 199870-day reviewClass I21 CFR 892.2010

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Parameter Developments, Inc. · LMB Device, Digital Image Storage, Radiological

Cleared on Apr 3, 1998 as substantially equivalent to K960326 (Fujifilm Medical System U.S.A., Inc., 1996) and 4 other predicates after a 70-day review. Its family tree reaches back 2 generations to 1993.

Decided
Apr 3, 1998
Review
70 days
Class
Class I
Product code
LMB
Recalls
None
Predicates
5

Its longest line of descent runs back 2 generations to K921112 (1993). 9 ancestors in all, the oldest K915094 (1991). No later device cites it as a predicate yet.

Other ancestors, by year cleared 1997: 1 other ancestor1996: 3 other ancestors1995: 1 other ancestor1993: 1 other ancestor1991: 1 other ancestorK921112 · Fuji Computed Radiography OD-F623 Optical-Disk · Fujifilm Medical System U.S.A., Inc. · 1993K960326 · FCR DMS Optical Disk Image Filing Unit OD-F614, ODF614L & Multimodality System · Fujifilm Medical System U.S.A., Inc. · 1996199019921994199619982000
Other ancestors, by generation 1 generation back: 4 other ancestors2 generations back: 3 other ancestors K960326 · FCR DMS Optical Disk Image Filing Unit OD-F614, ODF614L & Multimodality System · Fujifilm Medical System U.S.A., Inc. · 1996K921112 · Fuji Computed Radiography OD-F623 Optical-Disk · Fujifilm Medical System U.S.A., Inc. · 19930
  1. Root · 2 generations backK921112 Fuji Computed Radiography OD-F623 Optical-DiskFujifilm Medical System U.S.A., Inc. · 1993
  2. 1 generation backK960326 FCR DMS Optical Disk Image Filing Unit OD-F614, ODF614L &…Fujifilm Medical System U.S.A., Inc. · 1996
  3. This deviceK980243 Parameter Developments Dicom Archival Server, (Das)/Dicom Intranet…Parameter Developments, Inc. · 1998
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K921112Fuji Computed Radiography OD-F623 Optical-DiskFujifilm Medical System U.S.A., Inc.1993—
−1K960326FCR DMS Optical Disk Image Filing Unit OD-F614, ODF614L & Multimodality SystemFujifilm Medical System U.S.A., Inc.1996—
0 (this device)K980243Parameter Developments Dicom Archival Server, (Das)/Dicom Intranet Service (Dis)Parameter Developments, Inc.1998—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199110
199310
199510
199630
199710
FIG. 1 — Lineage of K980243, 1993–1998Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LMB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against? (5)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K960326FCR DMS Optical Disk Image Filing Unit OD-F614, ODF614L & Multimodality System
Summary page 1
…ing and Communications System Parameter Developments, DICOM Archival Server (DAS)/DICOM IntraNET Service (DIS) Fuji, FCR DMS Optical Disk Image Filing System, OD-F614, K960326 Lockheed, ECHONET, K960946 Kodak, Kodak Digital Science (KDS) Medical Image and Info, K960981 Base Ten Systems, UPACS Version 1.…
Fujifilm Medical System U.S.A., Inc.1996—
*K960946Echonet
Summary page 1
…em Parameter Developments, DICOM Archival Server (DAS)/DICOM IntraNET Service (DIS) Fuji, FCR DMS Optical Disk Image Filing System, OD-F614, K960326 Lockheed, ECHONET, K960946 Kodak, Kodak Digital Science (KDS) Medical Image and Info, K960981 Base Ten Systems, UPACS Version 1.7, K961160 Autocyt Group,…
Lockheed Martin Communications Systems1996—
*K960981Kodak Digital Science (KDS) Medical Image and Information Library
Summary page 1
…ET Service (DIS) Fuji, FCR DMS Optical Disk Image Filing System, OD-F614, K960326 Lockheed, ECHONET, K960946 Kodak, Kodak Digital Science (KDS) Medical Image and Info, K960981 Base Ten Systems, UPACS Version 1.7, K961160 Autocyt Group, Inc, AMICAS Web/Intranet Server, K970064 Device Description and Int…
Kodak Health Imaging Systems, Inc.1996—
*K961160Upacs Version 1.7
Summary page 1
…Image Filing System, OD-F614, K960326 Lockheed, ECHONET, K960946 Kodak, Kodak Digital Science (KDS) Medical Image and Info, K960981 Base Ten Systems, UPACS Version 1.7, K961160 Autocyt Group, Inc, AMICAS Web/Intranet Server, K970064 Device Description and Intended Use The DICOM Archival Server (DAS) so…
Base Ten Systems, Inc.1996—
*K970064Amicas Web/Intranet Image Server
Summary page 1
…K960946 Kodak, Kodak Digital Science (KDS) Medical Image and Info, K960981 Base Ten Systems, UPACS Version 1.7, K961160 Autocyt Group, Inc, AMICAS Web/Intranet Server, K970064 Device Description and Intended Use The DICOM Archival Server (DAS) software product provides for the centralized management an…
Autocyt Group, Inc.1997—

Also cleared against K960326: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 2.9 years on median.
  • None of the 9 ancestors has a recall.
  • 1 other device also cites its predicate K960326.

How does its category compare?

All LMB devices

LMB Device, Digital Image Storage, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LMB

FDA has decided no LMB device since 2007.

Median 510(k) review, days · LMB

Too few LMB 510(k)s in any year since 2007 to give a median.

Recalls per year · LMB

1in 2013

2008: 12009: 52011: 22013: 1
2007high 5 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LMB

7in 2025

2007: 12008: 32009: 32010: 162011: 42012: 42013: 72014: 12016: 212017: 102018: 52019: 102020: 82021: 102023: 102024: 92025: 7
2007high 21 (2016) · low 0 (2015)2025

MAUDE reports naming product code LMB, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—01
20080—13
20090—53
20100—016
20110—24
20120—04
20130—17
20140—01
20150—00
20160—021
20170—010
20180—05
20190—010
20200—08
20210—010
20220—00
20230—010
20240—09
20250—07
20260—0—

What is it indicated for?

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.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K960326

1 other device cites the same predicate.

  • K970293Fuji Computed Radiography FCR/Dicom Gateway Unit CR-DM666Fujifilm Medical System U.S.A., Inc. · 1997

Recent decisions in LMB

The LMB category page

  • K992131Samsung Raypax Long Term ArchiveSamsung Sds Co., Ltd. · 1999
  • K984405Echolive Family, Models: ZL-1010,ZL-2000,ZL-2100,ZL-3000,ZL-4000Intracom Corp. · 1999
  • K983447Wise (II) Image Management SystemSectra-Imtec AB · 19983 recalls
  • K973463Olicon Imaging Systems, Inc. Archive Systems, NT Archive, 02ARCHIVE, ArchiveO Tech, Inc. · 1997
  • K973413ID. Store (Release 2.0)I.S.G. Technologies, Inc. · 1997

https://510kreport.com/device/K980243 · printed Nov 3, 2026

Cite this page

510(k) Report. “K980243: Parameter Developments Dicom Archival Server, (Das)/Dicom Intranet Service (Dis).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K980243

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026