510(k) Report

510(k) · Cleared

Cleared

Hyperpacs Pacs and Telerafiology System

K950343510(k) TraditionalCleared Apr 12, 199575-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

Rogan Imaging Corp. · LMD System, Digital Image Communications, Radiological

Cleared on Apr 12, 1995 after a 75-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided
Apr 12, 1995
Review
75 days
Class
Class I
Product code
LMD
Recalls
None
Predicates
0

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

Descendants, by year cleared 1998: 1 descendant cleared2001: 1 descendant cleared1995200020052010201520202025
  1. This deviceK950343 Hyperpacs Pacs and Telerafiology SystemRogan Imaging Corp. · 1995
  2. Descendant · cites it directly · 1 of its ownK980296 Oldelft DigidelcaOldelft Corp. of America · 1998
  3. Descendant · 2 generations on · 0 of its ownK012165 Oldelft Thorascan Model Number 180TNucletron Corp. · 2001

Most influential descendants

Showing 2 of 2 · See all
  • K980296Oldelft DigidelcaOldelft Corp. of America · 1998 · cites it directly1descendant
  • K012165Oldelft Thorascan Model Number 180TNucletron Corp. · 2001 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K950343Hyperpacs Pacs and Telerafiology SystemRogan Imaging Corp.1995—
+1K980296Oldelft DigidelcaOldelft Corp. of America1998—
+2K012165Oldelft Thorascan Model Number 180TNucletron Corp.2001—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
200110
FIG. 1 — Lineage of K950343, 1995–2001Source: 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), 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?

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

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K980296Oldelft DigidelcaOldelft Corp. of America19981

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, K980296 (Oldelft Corp. of America, 1998) has gone furthest, with 1 descendant 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—

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/K950343 · printed Nov 4, 2026

Cite this page

510(k) Report. “K950343: Hyperpacs Pacs and Telerafiology System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K950343

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
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026