510(k) · Cleared
ClearedUniCam Evo Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inter Medical Medizintechnik GmbH · LLZ System, Image Processing, Radiological
Cleared on Apr 13, 2023 as substantially equivalent to K003437 (Philips Medical Systems (Cleveland), Inc., 2001) and 1 other predicate after a 58-day review. Its family tree reaches back 7 generations to 1993.
- Decided
- Apr 13, 2023
- Review
- 58 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K930090 (1993). 17 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK930090 HelicatElscint, Inc. · 1993
- 6 generations backK961464 Select/SPElscint, Inc. · 1996 · Recalled
- 5 generations backK982060 Volumax CT Imaging SystemElscint, Inc. · 1998
- 4 generations backK012009 MX8000 Idt CT SystemMarconi Medical Systems, Inc. · 2001 · Recalled
- 3 generations backK032036 Gemini 16Philips Medical Systems (Cleveland), Inc. · 2003 · Recalled
- 2 generations backK041182 SyntegraAdac Laboratories · 2004
- 1 generation backK081987 Unisyn Image Fusion, Version 1.0Convergent Imaging Solutions · 2008
- This deviceK230393 UniCam Evo SoftwareInter Medical Medizintechnik GmbH · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K930090 | Helicat | Elscint, Inc. | 1993 | — |
| −6 | K961464 | Select/SP | Elscint, Inc. | 1996 | 3 |
| −5 | K982060 | Volumax CT Imaging System | Elscint, Inc. | 1998 | — |
| −4 | K012009 | MX8000 Idt CT System | Marconi Medical Systems, Inc. | 2001 | 61 |
| −3 | K032036 | Gemini 16 | Philips Medical Systems (Cleveland), Inc. | 2003 | 2 |
| −2 | K041182 | Syntegra | Adac Laboratories | 2004 | — |
| −1 | K081987 | Unisyn Image Fusion, Version 1.0 | Convergent Imaging Solutions | 2008 | — |
| 0 (this device) | K230393 | UniCam Evo Software | Inter Medical Medizintechnik GmbH | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 4 | 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 |
|---|---|---|---|
| * | K003437 | Odyssey LX, Model 211320Summary page 5…ice(s): Manufacturer Device name 510(k) Number PHILIPS MEDICAL SYSTEMS (CLEVELAND), ODYSSEY LX, MODEL 211320 K003437 INC. 595 MINER RD. CONVERGENT IMAGING UniSyn Image Fusion K081987 SOLUTIONS 49 FIRST AVE. SUITE B O… | 2001 |
| * | K081987 | Unisyn Image Fusion, Version 1.0Summary page 5…ICAL SYSTEMS (CLEVELAND), ODYSSEY LX, MODEL 211320 K003437 INC. 595 MINER RD. CONVERGENT IMAGING UniSyn Image Fusion K081987 SOLUTIONS 49 FIRST AVE. SUITE B OTTAWA, ONTARIO, CA K1S 2G1 Device Description: UniCam Evo is a software package for processing… | 2008 |
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 30 years and passes through 6 companies; a new generation was cleared every 3.0 years on median.
- 7 of the 17 ancestors have a recall of any class.
- 2 other devices also cite its predicate K003437.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 UniCam Evo Software package is indicated for nuclear medicine image post-processing software for scintigraphic and SPECT imaging. UniCam Evo is indicated for processing and quantification of planar and tomographic bone scintigraphy scans, processing of cerebrovascular scintigraphic scans, processing of planar and tomographic cardiovascular scintigraphic studies, renal dynamic scans, planar and SPECT lung scintigraphy, planar gastrointestinal…
Read the full statement (177 words)
The UniCam Evo Software package is indicated for nuclear medicine image post-processing software for scintigraphic and SPECT imaging. UniCam Evo is indicated for processing and quantification of planar and tomographic bone scintigraphy scans, processing of cerebrovascular scintigraphic scans, processing of planar and tomographic cardiovascular scintigraphic studies, renal dynamic scans, planar and SPECT lung scintigraphy, planar gastrointestinal scintigraphic scans, liver scintigraphy, thyroid, parathyroid scintigraphy and displaying multimodal image fusion between SPECT/CT/MR/PET/ultrasound modalities.
The UniCam Evo Software is intended for nuclear medicine specialists, nuclear medicine radiologists, or trained medicine technologists. The operator shall have basic computer operation skills.
The software loads scintigraphic data sets in Dicom format from the local database or queries the corresponding dicom data from a PACS archive. The operator may perform analysis on the data, ROI analysis, tomographic reconstruction, organ dependent procedure steps and the software displays the results in form of images, numerical data or curves. The operator may print the results, store as an image or dicom secondary capture. Reconstructed transversal, coronal and sagittal slices can be also stored in Dicom 3.0 format.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230393 · printed Nov 4, 2026
Cite this page
510(k) Report. “K230393: UniCam Evo Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K230393
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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