510(k) · Cleared
ClearedUltrapacs
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ultrarad Corporation · LLZ System, Image Processing, Radiological
Cleared on Aug 15, 2005 as substantially equivalent to K042311 (Medical Standard Co., Ltd., 2004) and 1 other predicate after a 41-day review. Its family tree reaches back 4 generations to 2001.
- Decided
- Aug 15, 2005
- Review
- 41 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K010259 (2001). 7 ancestors in all, the oldest K002936 (2000). No later device cites it as a predicate yet.
- Root · 4 generations backK010259 Mediface PacsMediface Co., Ltd. · 2001
- 3 generations backK012844 Marosis PacsMarotech, Inc. · 2001
- 2 generations backK023460 PacsplusMedical Standard Co., Ltd. · 2003
- 1 generation backK042311 PacspartnerMedical Standard Co., Ltd. · 2004
- This deviceK051813 UltrapacsUltrarad Corporation · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K010259 | Mediface Pacs | Mediface Co., Ltd. | 2001 | — |
| −3 | K012844 | Marosis Pacs | Marotech, Inc. | 2001 | — |
| −2 | K023460 | Pacsplus | Medical Standard Co., Ltd. | 2003 | — |
| −1 | K042311 | Pacspartner | Medical Standard Co., Ltd. | 2004 | — |
| 0 (this device) | K051813 | Ultrapacs | Ultrarad Corporation | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 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 |
|---|---|---|---|
| * | K042311 | PacspartnerSummary page 1…Radiological Radiological Regulation Number 892.2050 892.2050 510(k) Number K042311 K041500 Device Name PACSPartner StarPACS Ortho Applicant… | 2004 |
| * | K041500 | Starpacs Orthopedics SystemSummary page 1…diological Radiological Regulation Number 892.2050 892.2050 510(k) Number K042311 K041500 Device Name PACSPartner StarPACS Ortho Applicant Medical Standard… | 2004 |
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 4 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- None of the 7 ancestors has a recall.
- 2 other devices also cite its predicate K042311.
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?
UltraPACSTM system is device that receives digital images and data from various sources (e.g. CT scanners, MR scanners, ultrasound systems, RIF Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. The device can also assists orthopedic…
Read the full statement (155 words)
UltraPACSTM system is device that receives digital images and data from various sources (e.g. CT scanners, MR scanners, ultrasound systems, RIF Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. The device can also assists orthopedic surgeons when doing preoperative planning and post-operative follow-up.
Options make possible reading (including mammography), telecommunications; fast demonstration; etc.; and teleconferencing.
Lossy compressed or digitized screen film mammographic images must not be reviewed for primary image interpretations. Only FFDM manufacturer processed images in DICOM "For Presentation" format can be displayed for primary interpretation. Mammographic images must only be interpreted using a FDA approved monitor that offers at least 5Mpixel resolutions and other technical specifications reviewed and accepted by the FDA.
Typical users of this system are trained professionals, physicians, nurses, and technicians.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051813 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051813: Ultrapacs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051813
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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