510(k) · Cleared
ClearedSony Digital Printer UP-D898MD/Sony Hybrid Printer UP-X898MD
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sony Electronics, Inc. · LMC Camera, Multi Format, Radiological
Cleared on Jun 26, 2014 as substantially equivalent to K890826 (Sony Corp. of America, 1989) after a 24-day review. Its family tree reaches back 1 generation to 1989.
- Decided
- Jun 26, 2014
- Review
- 24 days
- Class
- Class II
- Product code
- LMC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K890826 (1989). No later device cites it as a predicate yet.
- Root · 1 generation backK890826 Sony Video Graphic Printer UP-850Sony Corp. of America · 1989
- This deviceK141454 Sony Digital Printer UP-D898MD/Sony Hybrid Printer UP-X898MDSony Electronics, Inc. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K890826 | Sony Video Graphic Printer UP-850 | Sony Corp. of America | 1989 | — |
| 0 (this device) | K141454 | Sony Digital Printer UP-D898MD/Sony Hybrid Printer UP-X898MD | Sony Electronics, Inc. | 2014 | — |
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 LMC? 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 |
|---|---|---|---|
| * | K890826 | Sony Video Graphic Printer UP-850Summary page 1…The proposed Sony UP-D898MD (Digital) / IJP-X898MD (Hybrid) Printers are substantially equivalent to the Sony Video Graphic Printer UP-850, cleared under K890826. 4. DEVICE DESCRIPTION The Sony UP-DS98MD (Digital) / UP-X89SMD (Hybrid) Printers are compact, medical grade black a… | 1989 |
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.
How does its category compare?
All LMC devicesLMC Camera, Multi Format, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · LMC
2in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · LMC
80in 2009
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LMC
1in 2008
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LMC
2in 2018
MAUDE reports naming product code LMC, 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 | 1 | — | 0 | 0 |
| 2008 | 1 | — | 1 | 0 |
| 2009 | 3 | 80 | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 2 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Sony UP-DS98MD (Digital) / UP-XS9SMD (Hybrid) Printers are compact, medical grade black and white printers. The UP-DS98MD (Digital) only accepts digital signal inputs and the UP-XR9SMD (Hybrid) accepts both analog and digital signal inputs. Both printers are designed to be integrated into digital radiology imaging systems such as mobile c-arm, ultrasound, cardiac catheterization laboratory and other compatible medical imaging systems and produce hard copy prints of still images captured by these systems for the patient record or for referrals.
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/K141454 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141454: Sony Digital Printer UP-D898MD/Sony Hybrid Printer UP-X898MD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141454
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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