510(k) Report

510(k) · Cleared

Cleared

Imageshare Computed Radiography Acquisition Station and/or Software (2100{Sikarus X86}/(1500{Windows NT}

K973421510(k) TraditionalCleared Dec 5, 199786-day reviewClass I21 CFR 892.2020

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

Dejarnette Research Systems · LMD System, Digital Image Communications, Radiological

Cleared on Dec 5, 1997 after an 86-day review. The FDA summary names its predicate without a number.

Decided
Dec 5, 1997
Review
86 days
Class
Class I
Product code
LMD
Recalls
None
Predicates
0

The FDA summary names its predicate without a number.

FIG. 1 — Lineage of K973421Source: FDA 510(k) database · 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 LMD? 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? (1)

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
*—Imageshare Computed Radiography Acquisition Station and/or Software
Named without a submission number
—

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.

How does its category compare?

All LMD devices

LMD System, Digital Image Communications, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LMD

FDA has decided no LMD device since 2007.

Median 510(k) review, days · LMD

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

Recalls per year · LMD

2in 2020

2007: 22008: 12009: 12012: 12015: 12020: 2
2007high 2 (2007) · low 0 (2010)2026

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

Adverse event reports per year · LMD

16in 2025

2007: 12008: 22009: 32010: 92011: 12012: 22013: 42014: 122015: 92016: 32017: 22018: 42019: 22020: 22021: 22022: 62023: 72024: 82025: 16
2007high 16 (2025) · low 1 (2007)2025

MAUDE reports naming product code LMD, 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—21
20080—12
20090—13
20100—09
20110—01
20120—12
20130—04
20140—012
20150—19
20160—03
20170—02
20180—04
20190—02
20200—22
20210—02
20220—06
20230—07
20240—08
20250—016
20260—0—

What is it indicated for?

The Imageshare Computed Radiography Acquisition Station and/or Software is a bi-directional gateway that sends or receives digital images to/from various image sources (including, but not limited to, Fuji CR, Fuji HI-C654, Analogic Corporation’s DASM, Computed Radiography or Direct Radiography devices). The incoming data formats may be raw CR data, processed CR data or data formats proprietary to the modality source vendor. The Imageshare Computed Radiography Acquisition Station and/or Software converts the data to DICOM, ACR-NEMA v2.0, SPI format or other proprietary data format and transmits the data to one or more user-specified nodes across a standard, general purpose computing network.

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

More from Dejarnette Research Systems

9 FDA decisions under this applicant name. See the company

  • K974130Visishare Imaging System and/ or Software, Visishare System and/ or SoftwareDejarnette Research Systems · 1998
  • K973422Lasershare Print Spooler (2100[Solaris X86]/(1500[Windows NT])Dejarnette Research Systems · 1997
  • K963861Lasershare Print Spooler and/or SoftwareDejarnette Research Systems · 1996
  • K963592Imageshare Protocol Converting Gateway and/or Software [OS/2 Warp] 1OOO,[Sun/Solaris] 2000Dejarnette Research Systems · 1996
  • K963628Imageshare Computed Radiography Acquisition Station and/or SoftwareDejarnette Research Systems · 1996

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The LMD category page

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  • K991537Samsung Raypax SystemSamsung Sds Co., Ltd. · 1999

https://510kreport.com/device/K973421 · printed Nov 6, 2026

Cite this page

510(k) Report. “K973421: Imageshare Computed Radiography Acquisition Station and/or Software (2100{Sikarus X86}/(1500{Windows NT}.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973421

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