510(k) · Cleared
ClearedScimage Picomenterprise
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Scimage, Inc. · LLZ System, Image Processing, Radiological
Cleared on Jan 9, 2008 as substantially equivalent to K960911 (Scimage, Inc., 1996) and 2 other predicates after a 61-day review. Its family tree reaches back 5 generations to 1996.
- Decided
- Jan 9, 2008
- Review
- 61 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K954678 (1996). 8 ancestors in all, the oldest K945428 (1995). No later device cites it as a predicate yet.
- Root · 5 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 4 generations backK980648 Pro VisionAlgotec Systems, Ltd. · 1998
- 3 generations backK992654 Plug 'N View 3D, Version 1.0Voxar Limited · 1999
- 2 generations backK022970 Amicas Light Beam Workstation, Model 1.0Amicas, Inc. · 2002
- 1 generation backK062477 Amicas Vision Series Pacs, Model 4.3Amicas, Inc. · 2006
- This deviceK073169 Scimage PicomenterpriseScimage, Inc. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K954678 | Pro Vision | Algotec Systems, Ltd. | 1996 | — |
| −4 | K980648 | Pro Vision | Algotec Systems, Ltd. | 1998 | — |
| −3 | K992654 | Plug 'N View 3D, Version 1.0 | Voxar Limited | 1999 | — |
| −2 | K022970 | Amicas Light Beam Workstation, Model 1.0 | Amicas, Inc. | 2002 | — |
| −1 | K062477 | Amicas Vision Series Pacs, Model 4.3 | Amicas, Inc. | 2006 | — |
| 0 (this device) | K073169 | Scimage Picomenterprise | Scimage, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 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? (3)
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 |
|---|---|---|---|
| * | K960911 | Netra Workstation System & Netra MD SoftwareSummary page 1…Device 510(k) Number Sclmage, Inc. NetraTM Workstation and NetraMDTM Software K96091 1 Sclmage, Inc. NetraTM Workstation and NetraMDTM Software K003484 AMICAS… | 1996 |
| * | K003484 | Netra Workstation and Netramd SoftwareSummary page 1…c. NetraTM Workstation and NetraMDTM Software K96091 1 Sclmage, Inc. NetraTM Workstation and NetraMDTM Software K003484 AMICAS AMICAS Vision Series PACS 4.3 K062477 (4)Descrii~tion ofthe device: T… | 2001 |
| * | K062477 | Amicas Vision Series Pacs, Model 4.3Summary page 1…nc. NetraTM Workstation and NetraMDTM Software K003484 AMICAS AMICAS Vision Series PACS 4.3 K062477 (4)Descrii~tion ofthe device: The PicomEnterprise software is a multi-modality comprehensive two-, three- and four-dimensional im… | 2006 |
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 12 years and passes through 4 companies; a new generation was cleared every 2.5 years on median.
- None of the 8 ancestors has a recall.
- 3 other devices also cite its predicate K960911.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 PicomEnterprise software is intended for acceptance, transfer, display, storage and digital processing of medical images. Its hardware components may include digitizers, workstations, communications devices, computers, video monitors, magnetic, optical disk, or other digital data storage devices and hardcopy devices. The software components provide functions for performing operations related to image manipulation, enhancement, compression or…
Read the full statement (154 words)
The PicomEnterprise software is intended for acceptance, transfer, display, storage and digital processing of medical images.
Its hardware components may include digitizers, workstations, communications devices, computers, video monitors, magnetic, optical disk, or other digital data storage devices and hardcopy devices.
The software components provide functions for performing operations related to image manipulation, enhancement, compression or quantification.
To support the diagnostic interpretation of Mammography studies, PicomEnterprise will display the full fidelity DICOM image in a non-compressed format. Images will be rendered with patient and clinical information clearly displayed as part of the DICOM Overlay as required by MQSA, on monitors cleared by FDA for use in Digital Mammography. Lossy compressed mammography images and digitized film screen images should not be used for the purpose of primary diagnosis.
Mammographic images may only be interpreted using an FDA approved monitor that offers at least five megapixel resolution and meets other technical specifications reviewed and accepted by FDA.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073169 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073169: Scimage Picomenterprise.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073169
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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