510(k) Report

510(k) · Cleared

Cleared

Fuji Computed Radiography FCR/Dicom Gateway Unit CR-DM666

K970293510(k) TraditionalCleared Mar 21, 199756-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

Fujifilm Medical System U.S.A., Inc. · LMD System, Digital Image Communications, Radiological

Cleared on Mar 21, 1997 as substantially equivalent to K960326 (Fujifilm Medical System U.S.A., Inc., 1996) after a 56-day review. Its family tree reaches back 2 generations to 1993.

Decided
Mar 21, 1997
Review
56 days
Class
Class I
Product code
LMD
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K921112 (1993). No later device cites it as a predicate yet.

K921112 · 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. · 199619901992199419961998
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 deviceK970293 Fuji Computed Radiography FCR/Dicom Gateway Unit CR-DM666Fujifilm Medical System U.S.A., Inc. · 1997
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)K970293Fuji Computed Radiography FCR/Dicom Gateway Unit CR-DM666Fujifilm Medical System U.S.A., Inc.1997—
FIG. 1 — Lineage of K970293, 1993–1997Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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
Get a 510(k) Report

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
*K960326FCR DMS Optical Disk Image Filing Unit OD-F614, ODF614L & Multimodality System
Summary page 1
…4/L Series. FDA assigned the predicate to regulatory class II citing 21 CFR § 892.1750. FDA’s accession number for the premarket notification for the predicate device is K960326. FDA cleared the marketing of the predicate device in a letter dated March 7, 1996. Description of the Device [21 CFR 807.92(a)(…
Fujifilm Medical System U.S.A., Inc.1996—

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 4 years and passes through 1 company; a new generation was cleared every 2.9 years on median.
  • None of the 2 ancestors has a recall.
  • 1 other device also cites its predicate K960326.

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 indications for use of the FCR/DICOM Gateway Unit CR-DM666 is to serve as a gateway between a proprietary FCR DMS network and a standard ACR/NEMA Digital Imaging and Communications (DICOM) network.

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.

  • K980243Parameter Developments Dicom Archival Server, (Das)/Dicom Intranet Service (Dis)Parameter Developments, Inc. · 1998

More from Fujifilm Medical System U.S.A., Inc.

74 FDA decisions under this applicant name. See the company

  • K163675Processor VP-7000, Light Source BL-7000Fujifilm Medical System U.S.A., Inc. · 2017
  • K153206Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1Fujifilm Medical System U.S.A., Inc. · 2016
  • K151474Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter)Fujifilm Medical System U.S.A., Inc. · 2016
  • K152138FDR D-EVO GL Flat Panel Detector SystemFujifilm Medical System U.S.A., Inc. · 2015
  • K150221EPX-4440HD and EPX-4400HD with FICEFujifilm Medical System U.S.A., Inc. · 2015

Recent decisions in LMD

The LMD category page

  • K994329Iivs Integrated Image Viewing StationTerarecon,Inc. · 2000
  • K992698Stentor, PageviewStentor, Inc. · 1999
  • K992426Raypax Web Clinical SystemSamsung Sds Co., Ltd. · 1999
  • K992352ITR2000: Internet Teleradiology, Model Release 1.0Inteleradiology, Inc. · 1999
  • K991537Samsung Raypax SystemSamsung Sds Co., Ltd. · 1999

https://510kreport.com/device/K970293 · printed Nov 6, 2026

Cite this page

510(k) Report. “K970293: Fuji Computed Radiography FCR/Dicom Gateway Unit CR-DM666.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K970293

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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