510(k) · Cleared
ClearedHologic DR Imagepro
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hologic, Inc. · LLZ System, Image Processing, Radiological
Cleared on Oct 16, 2003 as substantially equivalent to K990241 (Accuimage Diagnostics Corp., 1999) after a 59-day review. Its family tree reaches back 4 generations to 1995.
- Decided
- Oct 16, 2003
- Review
- 59 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K945188 (1995). 10 ancestors in all, the oldest K864854 (1987). No later device cites it as a predicate yet.
- Root · 4 generations backK945188 Cemax Vipstation and/or SoftwareCemax, Inc. · 1995
- 3 generations backK961023 Aidp (Accuimage Image Display Processor)Accuimage, Inc. · 1996
- 2 generations backK982535 Insight Diagnostic Imaging WorkstationNeo Imagery Technologies, Inc. · 1998
- 1 generation backK990241 Accuimage, Accuview Diagnostic Imaging, Workstation W/Accuscore…Accuimage Diagnostics Corp. · 1999
- This deviceK032546 Hologic DR ImageproHologic, Inc. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K945188 | Cemax Vipstation and/or Software | Cemax, Inc. | 1995 | — |
| −3 | K961023 | Aidp (Accuimage Image Display Processor) | Accuimage, Inc. | 1996 | — |
| −2 | K982535 | Insight Diagnostic Imaging Workstation | Neo Imagery Technologies, Inc. | 1998 | — |
| −1 | K990241 | Accuimage, Accuview Diagnostic Imaging, Workstation W/Accuscore, Accuanalyze… | Accuimage Diagnostics Corp. | 1999 | — |
| 0 (this device) | K032546 | Hologic DR Imagepro | Hologic, Inc. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 3 | 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? (1)
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 |
|---|---|---|---|
| * | K990241 | Accuimage, Accuview Diagnostic Imaging, Workstation W/Accuscore, Accuanalyze, Accuscope…Summary page 1…21 CFR 820.2050 Product Code: 90 LLZ Common/Usual Name Medical Image Management Device H.5 Predicate Device Information K990241 Acculmage Diagnostics Corp. AccuView Diagnostic Imaging Software Package with Plug- ins. H.6 Device Description and Intended… | 1999 |
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 8 years and passes through 5 companies; a new generation was cleared every 2.3 years on median.
- None of the 10 ancestors has a recall.
- 5 other devices also cite its predicate K990241.
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?
The Hologic DR ImagePro is a Windows-based software application acting as a Picture Archiving and Communications System (PACS). It is intended to be used by clinical professionals to view, manipulate, transmit, print, and store DICOM compliant digital radiographic image data. It provides standard tools for image zoom, rotation, enhancement, smoothing, and sharpening. Hologic DR ImagePro also provides software tools for merging two to five DICOM image…
Read the full statement (115 words)
The Hologic DR ImagePro is a Windows-based software application acting as a Picture Archiving and Communications System (PACS). It is intended to be used by clinical professionals to view, manipulate, transmit, print, and store DICOM compliant digital radiographic image data. It provides standard tools for image zoom, rotation, enhancement, smoothing, and sharpening. Hologic DR ImagePro also provides software tools for merging two to five DICOM image files of an individual patient together to aid visualization of large areas of interest. The software assists users in merging, or "stitching," the separate images together manually and allows users to draw lines and angles within the images to obtain measurements. The software runs on standard, off-the-shelf PC components.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032546 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032546: Hologic DR Imagepro.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032546
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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