510(k) Report

510(k) · Cleared

Cleared

Vortech's Image Archival and Retrieval System

K915094510(k) TraditionalCleared Dec 27, 199145-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

Vortech Data, Inc. · LMB Device, Digital Image Storage, Radiological

Cleared on Dec 27, 1991 after a 45-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.

Decided
Dec 27, 1991
Review
45 days
Class
Class I
Product code
LMB
Recalls
None
Predicates
0

3 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 1996: 1 descendant cleared1998: 1 descendant cleared1997: 1 descendant cleared1990200020102020
  1. This deviceK915094 Vortech's Image Archival and Retrieval SystemVortech Data, Inc. · 1991
  2. Descendant · cites it directly · 2 of its ownK960981 Kodak Digital Science (KDS) Medical Image and Information LibraryKodak Health Imaging Systems, Inc. · 1996
  3. Descendant · 2 generations on · 0 of its ownK980243 Parameter Developments Dicom Archival Server, (Das)/Dicom Intranet…Parameter Developments, Inc. · 1998
  4. Descendant · 2 generations on · 0 of its ownK972380 Kodak Digital Science (KDS) Medical Image and Information Library…Eastman Kodak Company · 1997

Most influential descendants

Showing 3 of 3 · See all
  • K960981Kodak Digital Science (KDS) Medical Image and Information LibraryKodak Health Imaging Systems, Inc. · 1996 · cites it directly2descendants
  • K980243Parameter Developments Dicom Archival Server, (Das)/Dicom Intranet Service (Dis)Parameter Developments, Inc. · 1998 · 2 generations on0descendants
  • K972380Kodak Digital Science (KDS) Medical Image and Information Library (Miil)Eastman Kodak Company · 1997 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K915094Vortech's Image Archival and Retrieval SystemVortech Data, Inc.1991—
+1K960981Kodak Digital Science (KDS) Medical Image and Information LibraryKodak Health Imaging Systems, Inc.1996—
+2K980243Parameter Developments Dicom Archival Server, (Das)/Dicom Intranet Service (Dis)Parameter Developments, Inc.1998—
+2K972380Kodak Digital Science (KDS) Medical Image and Information Library (Miil)Eastman Kodak Company1997—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
199710
199810
FIG. 1 — Lineage of K915094, 1991–1998Source: 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), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (3)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K960981Kodak Digital Science (KDS) Medical Image and Information LibraryKodak Health Imaging Systems, Inc.19962

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?

  • Of its descendants, K960981 (Kodak Health Imaging Systems, Inc., 1996) has gone furthest, with 2 descendants of its own.

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—

More from Vortech Data, Inc.

11 FDA decisions under this applicant name. See the company

  • K924366Personal Display SystemVortech Data, Inc. · 1993
  • K925097Vortech's Autorouter (Automatic Image Routing)Vortech Data, Inc. · 1993
  • K924229VG-a MigVortech Data, Inc. · 1992
  • K922310Vortech's Personal Display SystemVortech Data, Inc. · 1992
  • K915362Vortech's Film Digitizer, FD-1Vortech Data, Inc. · 1992

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
  • K980243Parameter Developments Dicom Archival Server, (Das)/Dicom Intranet Service (Dis)Parameter Developments, Inc. · 1998
  • K973463Olicon Imaging Systems, Inc. Archive Systems, NT Archive, 02ARCHIVE, ArchiveO Tech, Inc. · 1997

https://510kreport.com/device/K915094 · printed Nov 5, 2026

Cite this page

510(k) Report. “K915094: Vortech's Image Archival and Retrieval System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K915094

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026