510(k) · Cleared
ClearedSamsung Raypax System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Samsung Sds Co., Ltd. · LMD System, Digital Image Communications, Radiological
Cleared on Jul 6, 1999 as substantially equivalent to K922164 (Olicon Imaging Systems, Inc., 1993) after a 64-day review. Its family tree reaches back 1 generation to 1993.
- Decided
- Jul 6, 1999
- Review
- 64 days
- Class
- Class I
- Product code
- LMD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K922164 (1993). No later device cites it as a predicate yet.
- Root · 1 generation backK922164 Raytel Digital Imaging SystemsOlicon Imaging Systems, Inc. · 1993
- This deviceK991537 Samsung Raypax SystemSamsung Sds Co., Ltd. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K922164 | Raytel Digital Imaging Systems | Olicon Imaging Systems, Inc. | 1993 | — |
| 0 (this device) | K991537 | Samsung Raypax System | Samsung Sds Co., Ltd. | 1999 | — |
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
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 | Decided |
|---|---|---|---|
| * | K922164 | Raytel Digital Imaging SystemsSummary page 1…ge Communications, accessory Predicate Device: 21 cFRr 807. 92(a)(3) Manufacturer: Olicon Imaging Systems, Inc. Device: RAYTEL™ DIGITAL IMAGING SYSTEMS 510(k) Number: K922164 Date Received: 05/08/92 Decision Date: 01/21/93 Decision: Substantially Equivalent Panel Code device reviewed by: Radiology P… | 1993 |
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?
- Its one ancestor has no recall.
- 3 other devices also cite its predicate K922164.
How does its category compare?
All LMD devicesLMD 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
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LMD
16in 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 | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 2 | 1 |
| 2008 | 0 | — | 1 | 2 |
| 2009 | 0 | — | 1 | 3 |
| 2010 | 0 | — | 0 | 9 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 1 | 2 |
| 2013 | 0 | — | 0 | 4 |
| 2014 | 0 | — | 0 | 12 |
| 2015 | 0 | — | 1 | 9 |
| 2016 | 0 | — | 0 | 3 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 4 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 2 | 2 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 6 |
| 2023 | 0 | — | 0 | 7 |
| 2024 | 0 | — | 0 | 8 |
| 2025 | 0 | — | 0 | 16 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Samsung RAYPAX™ is a device that receives digital images and data from various sources (including but not limited to CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations.
Typical users of this system are trained professionals, including but not limited to physicians, nurses, and technicians.
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/K991537 · printed Nov 5, 2026
Cite this page
510(k) Report. “K991537: Samsung Raypax System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K991537
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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