510(k) · Cleared
ClearedPMD Viewer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spencer Technologies · LLZ System, Image Processing, Radiological
Cleared on Oct 8, 2009 as substantially equivalent to K022896 (Acuson Corp., 2002) and 1 other predicate after a 78-day review. Its family tree reaches back 5 generations to 1994.
- Decided
- Oct 8, 2009
- Review
- 78 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K934041 (1994). 10 ancestors in all, the oldest K891689 (1989). No later device cites it as a predicate yet.
- Root · 5 generations backK934041 Hewlett Packard Conos Ultrasound Imaging System ModificationHewlett-Packard Co. · 1994
- 4 generations backK964309 Sonos 2000, Sonos 2500 (M2406 a)Hewlett-Packard Co. · 1997
- 3 generations backK982800 Ecton Lynx Ultrasound SystemEcton, Inc. · 1998
- 2 generations backK021497 Cypress Ultrasound SystemAcuson Corp. · 2002 · Recalled
- 1 generation backK022896 CSV12 Software ViewerAcuson Corp. · 2002
- This deviceK092204 PMD ViewerSpencer Technologies · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K934041 | Hewlett Packard Conos Ultrasound Imaging System Modification | Hewlett-Packard Co. | 1994 | — |
| −4 | K964309 | Sonos 2000, Sonos 2500 (M2406 a) | Hewlett-Packard Co. | 1997 | — |
| −3 | K982800 | Ecton Lynx Ultrasound System | Ecton, Inc. | 1998 | — |
| −2 | K021497 | Cypress Ultrasound System | Acuson Corp. | 2002 | 2 |
| −1 | K022896 | CSV12 Software Viewer | Acuson Corp. | 2002 | — |
| 0 (this device) | K092204 | PMD Viewer | Spencer Technologies | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1994 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
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? (2)
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 |
|---|---|---|---|
| * | K022896 | CSV12 Software ViewerSummary page 1…Manufacturer Trade Name 510(k ) No Product Code Acuson Corporation CSV12 Software Viewer K022896 90 LLZ Spencer Technologies TCD 100M/PMD150 Diagnostic K002533 90 IYN… | 2002 |
| * | K002533 | TCD 100M, PWD13 TransducerSummary page 1…e Acuson Corporation CSV12 Software Viewer K022896 90 LLZ Spencer Technologies TCD 100M/PMD150 Diagnostic K002533 90 IYN Ultrasound System Note: In this document we refer to the Acuson Vie… | 2000 |
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 15 years and passes through 4 companies; a new generation was cleared every 2.6 years on median.
- 2 of the 10 ancestors have a recall of any class.
- 2 other devices also cite its predicate K022896.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
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 PMD Viewer Software is intended to provide off-line data viewing, playback, and report generation features of transcranial TCD100M/PMD150O Doppler ultrasound studies on a PC. PMD Viewer may only be operated independently, as a software-only product. PMD Viewer is intended for use by a technologist or physician trained in the use of Doppler ultrasound. PMD Viewer is NOT intended to replace any means of evaluating vital patient physiological processes. No new intended uses are claimed.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092204 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092204: PMD Viewer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092204
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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