510(k) Report

510(k) · Cleared

Cleared

Star Technologies, Inc. Film Image Scan System

K952914510(k) TraditionalCleared Sep 18, 199584-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

Star Technologies, Inc. · LMD System, Digital Image Communications, Radiological

Cleared on Sep 18, 1995 after an 84-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 7 later devices descend from it.

Decided
Sep 18, 1995
Review
84 days
Class
Class I
Product code
LMD
Recalls
None
Predicates
0

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

Descendants, by year cleared 1997: 1 descendant cleared1998: 1 descendant cleared2002: 1 descendant cleared2001: 1 descendant cleared2005: 1 descendant cleared2014: 1 descendant cleared2025: 1 descendant cleared1995200020052010201520202025
  1. This deviceK952914 Star Technologies, Inc. Film Image Scan SystemStar Technologies, Inc. · 1995
  2. Descendant · cites it directly · 6 of its ownK972191 Digitizer Director (HSC025-01)Howtek, Inc. · 1997
  3. Descendant · 2 generations on · 5 of its ownK980213 DI-2000Lumisys, Inc. · 1998
  4. Descendant · 3 generations on · 3 of its ownK020243 Laserpro 16Eradlink, Inc. · 2002
  5. Descendant · 4 generations on · 2 of its ownK052938 CR-PROEradlink, Inc. · 2005
  6. Descendant · 4 generations on · 1 of its ownK142718 Radlink GPSRadlink, Inc. · 2014

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

1997: 11998: 12001: 12002: 12005: 12014: 12025: 1
1997high 1 (1997) · low 0 (1999)2026

Most influential descendants

Showing 5 of 7 · See all
  • K972191Digitizer Director (HSC025-01)Howtek, Inc. · 1997 · cites it directly6descendants
  • K980213DI-2000Lumisys, Inc. · 1998 · 2 generations on5descendants
  • K020243Laserpro 16Eradlink, Inc. · 2002 · 3 generations on3descendants
  • K052938CR-PROEradlink, Inc. · 2005 · 4 generations on2descendants
  • K142718Radlink GPSRadlink, Inc. · 2014 · 4 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K952914Star Technologies, Inc. Film Image Scan SystemStar Technologies, Inc.1995—
+1K972191Digitizer Director (HSC025-01)Howtek, Inc.1997—
+2K980213DI-2000Lumisys, Inc.1998—
+3K020243Laserpro 16Eradlink, Inc.2002—
+4K052938CR-PROEradlink, Inc.2005—
+4K142718Radlink GPSRadlink, Inc.2014—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
199810
200110
200210
200510
201410
202510
FIG. 1 — Lineage of K952914, 1995–2025Source: 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.

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  • 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? (7)

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

NumberDeviceApplicantDecidedDescendants
K972191Digitizer Director (HSC025-01)Howtek, Inc.19976

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, K972191 (Howtek, Inc., 1997) has gone furthest, with 6 descendants of its own.

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—

More from Star Technologies, Inc.

2 FDA decisions under this applicant name. See the company

  • K951141Star Technolgies, Inc. Image Management ServerStar Technologies, Inc. · 1995

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https://510kreport.com/device/K952914 · printed Nov 6, 2026

Cite this page

510(k) Report. “K952914: Star Technologies, Inc. Film Image Scan System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K952914

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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