510(k) · Cleared
ClearedUpacs Version 1.7
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Base Ten Systems, Inc. · LMB Device, Digital Image Storage, Radiological
Cleared on Jun 11, 1996 after an 81-day review. The FDA summary names its predicate without a number. 1 of the 357 devices in its family, counting itself, has a Class I recall. 356 later devices descend from it.
- Decided
- Jun 11, 1996
- Review
- 81 days
- Class
- Class I
- Product code
- LMB
- Recalls
- None
- Predicates
- 0
356 later devices descend from it, 2 citing it directly. 1 of the 357 devices in this family, counting this one, has a Class I recall.
- This deviceK961160 Upacs Version 1.7Base Ten Systems, Inc. · 1996
- Descendant · cites it directly · 354 of its ownK981535 Focus Pilot Contouring WorkstationComputerized Medical Systems, Inc. · 1999
- Descendant · 2 generations on · 353 of its ownK052379 Mim 3.5 (Circa)Mimvista Corp. · 2005
- Descendant · 3 generations on · 350 of its ownK060816 Mim 4.0 (NeuroMimvista Corp. · 2006 · Recalled
- Descendant · 4 generations on · 287 of its ownK071964 Mim 4.1 (Seastar)Mimvista Corp. · 2007 · Recalled
- Descendant · 5 generations on · 200 of its ownK091373 Syngo TruedSiemens Medical Solutions USA, Inc. · 2009
Showing 5 of 356 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K250443 MAGNETOM Avanto Fit; MAGNETOM Skyra Fit…10 generations on · 2025
Most influential descendants
Showing 5 of 356 · See all- K981535Focus Pilot Contouring WorkstationComputerized Medical Systems, Inc. · 1999 · cites it directly354descendants
- K052379Mim 3.5 (Circa)Mimvista Corp. · 2005 · 2 generations on353descendants
- K060816Mim 4.0 (NeuroMimvista Corp. · 2006 · 3 generations on350descendants
- K071964Mim 4.1 (Seastar)Mimvista Corp. · 2007 · 4 generations on287descendants
- K091373Syngo TruedSiemens Medical Solutions USA, Inc. · 2009 · 5 generations on200descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K961160 | Upacs Version 1.7 | Base Ten Systems, Inc. | 1996 | — |
| +1 | K981535 | Focus Pilot Contouring Workstation | Computerized Medical Systems, Inc. | 1999 | — |
| +2 | K052379 | Mim 3.5 (Circa) | Mimvista Corp. | 2005 | — |
| +3 | K060816 | Mim 4.0 (Neuro | Mimvista Corp. | 2006 | 1 |
| +4 | K071964 | Mim 4.1 (Seastar) | Mimvista Corp. | 2007 | 2 |
| +5 | K091373 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 6 | 0 |
| 2011 | 6 | 0 |
| 2012 | 8 | 0 |
| 2013 | 6 | 0 |
| 2014 | 11 | 0 |
| 2015 | 12 | 0 |
| 2016 | 14 | 0 |
| 2017 | 17 | 0 |
| 2018 | 24 | 0 |
| 2019 | 23 | 0 |
| 2020 | 28 | 0 |
| 2021 | 25 | 0 |
| 2022 | 32 | 0 |
| 2023 | 30 | 0 |
| 2024 | 28 | 0 |
| 2025 | 39 | 1 |
| 2026 | 36 | 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.
1 device in this family has a Class I recall. 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? (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 |
|---|---|---|---|
| * | — | Intrascan Named without a submission number | |
| * | — | Instrascan I Named without a submission number |
What descends from it? (356)
See all 3562 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH · 2025 · 10 generations on · ◆ in the 2025 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- Of its descendants, K981535 (Computerized Medical Systems, Inc., 1999) has gone furthest, with 354 descendants of its own.
How does its category compare?
All LMB devicesLMB Device, Digital Image Storage, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LMB
FDA has decided no LMB device since 2007.
Median 510(k) review, days · LMB
Too few LMB 510(k)s in any year since 2007 to give a median.
Recalls per year · LMB
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LMB
7in 2025
MAUDE reports naming product code LMB, 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 | — | 0 | 1 |
| 2008 | 0 | — | 1 | 3 |
| 2009 | 0 | — | 5 | 3 |
| 2010 | 0 | — | 0 | 16 |
| 2011 | 0 | — | 2 | 4 |
| 2012 | 0 | — | 0 | 4 |
| 2013 | 0 | — | 1 | 7 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 21 |
| 2017 | 0 | — | 0 | 10 |
| 2018 | 0 | — | 0 | 5 |
| 2019 | 0 | — | 0 | 10 |
| 2020 | 0 | — | 0 | 8 |
| 2021 | 0 | — | 0 | 10 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 10 |
| 2024 | 0 | — | 0 | 9 |
| 2025 | 0 | — | 0 | 7 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
uPACS™ Version 1.7 is a software controlled microprocessor based archiving system using installed proprietary software for recording, storage and presentation of video ultrasound images. The system is designed for use with FDA approved ultrasound imaging equipment which provides video output and is approved for operation and use in the patient environement.
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/K961160 · printed Nov 6, 2026
Cite this page
510(k) Report. “K961160: Upacs Version 1.7.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K961160
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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