510(k) · Cleared

Cleared

JPACS

K980918510(k) TraditionalCleared Jun 3, 199884-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

Philips Medical Systems (Cleveland), Inc. · LMD System, Digital Image Communications, Radiological

Cleared on Jun 3, 1998 as substantially equivalent to K971347 (International Regulatory Consultants, 1997) after an 84-day review. Its family tree reaches back 2 generations to 1996.

Decided: Jun 3, 1998
Review: 84 days
Class: Class I
Product code: LMD
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K954678 (1996). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
1 generation backK971347 MedisurfInternational Regulatory Consultants · 1997
This deviceK980918 JPACSPhilips Medical Systems (Cleveland), Inc. · 1998

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K954678	Pro Vision	Algotec Systems, Ltd.	1996	—
−1	K971347	Medisurf	International Regulatory Consultants	1997	—
0 (this device)	K980918	JPACS	Philips Medical Systems (Cleveland), Inc.	1998	—

FIG. 1 — Lineage of K980918, 1996–1998Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K971347	Medisurf Summary page 1 …laims equivalence to the legally marketed device identified as the Medisurf manufactured by Algotec Systems Ltd. granted marketing permission in Document Control Number K971347. 3 JPAC BSTANTIAL EQUIVALENCE SUMMARY K980918, page 2 OF 3 (4) A description of the device that is the subject…	International Regulatory Consultants	1997	—

Also cleared against K971347: 4 other devices →

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 2 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
None of the 2 ancestors has a recall.
4 other devices also cite its predicate K971347.

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

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

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

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	2	1
2008	—	1	2
2009	—	1	3
2010	—	0	9
2011	—	0	1
2012	—	1	2
2013	—	0	4
2014	—	0	12
2015	—	1	9
2016	—	0	3
2017	—	0	2
2018	—	0	4
2019	—	0	2
2020	—	2	2
2021	—	0	2
2022	—	0	6
2023	—	0	7
2024	—	0	8
2025	—	0	16
2026	—	0	—

What is it indicated for?

The JPACS radiology suite provides access to clinical reports and images via computer networks. Given the following information objects, the JPACS radiology suite may be used on any part of the human anatomy: CR, CT, MR, XA, SC, US, NM, PET, and RT. The suite also provides short, medium, and long term storage of these clinical images from any authorized workstation within an intranet or over the Internet. The full feature imaging suite can be used for in-house image distribution, on-call teleradiology, and advance visual display features. The JPACS radiology suite also includes functionality for generation and distribution of clinical reports.

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

https://510kreport.com/device/K980918 · printed Nov 6, 2026

Cite this page

510(k) Report. “K980918: JPACS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980918

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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