510(k) · Cleared
ClearedSony Hybird Graphic UP-971AD, Sony Hybird Graphic Printer UP-991AD
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 K882958 (Sony Medical Electronics Co., 1988) after a 35-day review. Its family tree reaches back 1 generation to 1988.
- Decided
- Jun 26, 2014
- Review
- 35 days
- Class
- Class II
- Product code
- LMC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K882958 (1988). No later device cites it as a predicate yet.
- Root · 1 generation backK882958 Sony Video Printers, UP SeriesSony Medical Electronics Co. · 1988
- This deviceK141346 Sony Hybird Graphic UP-971AD, Sony Hybird Graphic Printer UP-991ADSony Electronics, Inc. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K882958 | Sony Video Printers, UP Series | Sony Medical Electronics Co. | 1988 | — |
| 0 (this device) | K141346 | Sony Hybird Graphic UP-971AD, Sony Hybird Graphic Printer UP-991AD | 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 |
|---|---|---|---|
| * | K882958 | Sony Video Printers, UP SeriesSummary page 1…umber: 21 CFR 892.2040 Product Code: [MC 3. PREDICATE DEVICES The following devices are legally marketed devices cleared under K882958 as Sony UP Series Video Printers to which equivalence is being claimed: " UP-701 Video Graphic Printer… | 1988 |
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?
Sony Hybrid Graphic Printers UP-971AD and UP-991AD are compact, medical grade black and white printers that can accept both analog and digital signal inputs. They are designed to be integrated into 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 as stated in the FDA summary.
https://510kreport.com/device/K141346 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141346: Sony Hybird Graphic UP-971AD, Sony Hybird Graphic Printer UP-991AD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141346
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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