510(k) · Cleared
ClearedDownscan 120
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Merlin Engineering Works, Inc. · LLZ System, Image Processing, Radiological
Cleared on Apr 7, 1997 as substantially equivalent to K953398 (Merlin Engineering Works, Inc., 1995) after a 60-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Apr 7, 1997
- Review
- 60 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K953398 (1995). No later device cites it as a predicate yet.
- Root · 1 generation backK953398 UniscanMerlin Engineering Works, Inc. · 1995
- This deviceK970451 Downscan 120Merlin Engineering Works, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K953398 | Uniscan | Merlin Engineering Works, Inc. | 1995 | — |
| 0 (this device) | K970451 | Downscan 120 | Merlin Engineering Works, Inc. | 1997 | — |
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 LLZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LLZ device
- #1 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K953398 | UniscanSummary page 1…-954 Common Name: Video Scan Converter (or Digital Scan Converter) Classification (A component of) stationary x-ray system, per 21 Name: CFR 892.1689 (or equivalent) K953398 UniScan Merlin Engineering Works DownScan 120 is a digital image processing system that can convert from very-high-line rate vid… | 1995 |
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.
- 4 other devices also cite its predicate K953398.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, 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 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
What is it indicated for?
The intended use for DownScan 120 is conversion of X-ray (stationary, C-arm, angiography, etc.), nuclear medicine, magnetic resonance, and ultrasound images either directly from their source, or from an intermediate storage device (like a video tape or video disk), for use on display monitors, optical, tape or disk recorders, or other apparatus requiring a standard frame rate video signal (30 or 25 frames/second). The use of DownScan 120 is indicated…
Read the full statement (116 words)
The intended use for DownScan 120 is conversion of X-ray (stationary, C-arm, angiography, etc.), nuclear medicine, magnetic resonance, and ultrasound images either directly from their source, or from an intermediate storage device (like a video tape or video disk), for use on display monitors, optical, tape or disk recorders, or other apparatus requiring a standard frame rate video signal (30 or 25 frames/second). The use of DownScan 120 is indicated whenever the source and destination of a video signal are incompatible due to different line and/or frame rates, and a standard frame rate video signal is required.
DownScan 120 is intended for use in patient care areas, but is not intended to have any patient contact.
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/K970451 · printed Nov 4, 2026
Cite this page
510(k) Report. “K970451: Downscan 120.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970451
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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