510(k) · Cleared

Cleared

Samsung Raypax Long Term Archive

K992131510(k) TraditionalCleared Sep 13, 199982-day reviewClass I21 CFR 892.2010

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

Samsung Sds Co., Ltd. · LMB Device, Digital Image Storage, Radiological

Cleared on Sep 13, 1999 as substantially equivalent to K973463 (O Tech, Inc., 1997) after an 82-day review. Its family tree reaches back 2 generations to 1993.

Decided: Sep 13, 1999
Review: 82 days
Class: Class I
Product code: LMB
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K922164 (1993). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK922164 Raytel Digital Imaging SystemsOlicon Imaging Systems, Inc. · 1993
1 generation backK973463 Olicon Imaging Systems, Inc. Archive Systems, NT Archive, 02ARCHIVE…O Tech, Inc. · 1997
This deviceK992131 Samsung Raypax Long Term ArchiveSamsung Sds Co., Ltd. · 1999

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K922164	Raytel Digital Imaging Systems	Olicon Imaging Systems, Inc.	1993	—
−1	K973463	Olicon Imaging Systems, Inc. Archive Systems, NT Archive, 02ARCHIVE, Archive	O Tech, Inc.	1997	—
0 (this device)	K992131	Samsung Raypax Long Term Archive	Samsung Sds Co., Ltd.	1999	—

FIG. 1 — Lineage of K992131, 1993–1999Source: 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 LMB? 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
*	K973463	Olicon Imaging Systems, Inc. Archive Systems, NT Archive, 02ARCHIVE, Archive Summary page 1 …e Classification: 21 CFR 892.2010 Predicate Device: 21 CFR 807. 92(a)(3) Manufacturer: Olicon Imaging Systems, Inc. Device: Olicon Imaging Systems Archive 510(k) Number: K973463 Date Received: 09/12/97 Decision Date: 12/02/97 Decision: Substantially Equivalent Panel Code device reviewed by: Radiology Pane…	O Tech, Inc.	1997	—

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 6 years and passes through 3 companies; a new generation was cleared every 4.9 years on median.
None of the 2 ancestors has a recall.

How does its category compare?

All LMB devices

LMB Device, Digital Image Storage, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LMB

FDA has decided no LMB device since 2007.

Median 510(k) review, days · LMB

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

Recalls per year · LMB

1in 2013

2007high 5 (2009) · low 0 (2007)2026

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

Adverse event reports per year · LMB

7in 2025

2007high 21 (2016) · low 0 (2015)2025

MAUDE reports naming product code LMB, 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	—	0	1
2008	—	1	3
2009	—	5	3
2010	—	0	16
2011	—	2	4
2012	—	0	4
2013	—	1	7
2014	—	0	1
2015	—	0	0
2016	—	0	21
2017	—	0	10
2018	—	0	5
2019	—	0	10
2020	—	0	8
2021	—	0	10
2022	—	0	0
2023	—	0	10
2024	—	0	9
2025	—	0	7
2026	—	0	—

What is it indicated for?

The Samsung RAYPAX™ Archive will be used to store & retrieve digital medical images and information about the images.

The typical users are trained medical professionals.

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/K992131 · printed Nov 6, 2026

Cite this page

510(k) Report. “K992131: Samsung Raypax Long Term Archive.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992131

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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