# K091368: R2 Digitalnow HD (Digitalnow HD)

- Pathway: 510(k) (Traditional)
- Applicant: Hologic, Inc.
- Decided: Jun 4, 2009 after 27 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K913770 (1991). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080351: Dexela Dex Top Mammography Workstation, Model Mamwkvi, Dexela, Ltd. (2008) Summary page 1.

## Most influential descendants
- K123530: Mammography Prior Enhancement (Mpe) (2012), 0 descendants of its own

## Indications for use
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).

Source page: https://510kreport.com/device/K091368
Methodology: https://510kreport.com/methodology