510(k) · Cleared
ClearedR2 Digitalnow HD (Digitalnow HD)
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 Jun 4, 2009 as substantially equivalent to K080351 (Dexela, Ltd., 2008) after a 27-day review. Its family tree reaches back 5 generations to 1991. 1 later device descends from it.
- Decided
- Jun 4, 2009
- Review
- 27 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K913770 (1991). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 4 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 3 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- 2 generations backK033400 Seno AdvantageGe Medical Systems W-400 · 2003 · Recalled
- 1 generation backK080351 Dexela Dex Top Mammography Workstation, Model MamwkviDexela, Ltd. · 2008
- This deviceK091368 R2 Digitalnow HD (Digitalnow HD)Hologic, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK123530 Mammography Prior Enhancement (Mpe)Hologic, Inc. · 2012
Most influential descendants
Showing 1 of 1 · See all- K123530Mammography Prior Enhancement (Mpe)Hologic, Inc. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −4 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −3 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| −2 | K033400 | Seno Advantage | Ge Medical Systems W-400 | 2003 | 6 |
| −1 | K080351 | Dexela Dex Top Mammography Workstation, Model Mamwkvi | Dexela, Ltd. | 2008 | — |
| 0 (this device) | K091368 | R2 Digitalnow HD (Digitalnow HD) | Hologic, Inc. | 2009 | — |
| +1 | K123530 | Mammography Prior Enhancement (Mpe) | Hologic, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 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? (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 |
|---|---|---|---|
| * | K080351 | Dexela Dex Top Mammography Workstation, Model MamwkviSummary page 1…90-LLZ Predicate Devices: The predicate device for DigitalNow HD software is certain software functions contained in the following device: K08035 1, Apr 22, 2008 DexTop Mammography Workstation [Dexela Limited] Section B.lI… | 2008 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123530 | Mammography Prior Enhancement (Mpe) | 2012 | 0 |
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 18 years and passes through 5 companies; a new generation was cleared every 4.3 years on median.
- 2 of the 6 ancestors have a recall of any class.
- Of its descendants, K123530 (Hologic, Inc., 2012) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
R2 DigitalNow HD is a software application intended to process digitized screen-film mammograms for comparison purposes only. The software processes digitized prior film images to produce lossy-compressed DICOM images that more closely resemble digital mammography images. R2 DigitalNow HDI images are intended for comparison purposes only and cannot be used for primary diagnosis.
DigitalNow H]D is a software application which runs on the Hologic Cenova server (Class I exempt per 21 CFR § 892.2010 and 21 CFR § 892.2020).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091368 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091368: R2 Digitalnow HD (Digitalnow HD).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091368
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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