# K070322: Syngo Dynamics, Version 6.0

- Pathway: 510(k) (Special)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Feb 27, 2007 after 25 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K954479 (1996). 10 ancestors in all.
9 later devices descend from it; 1 cites it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061995: Xcelera, Philips Medical Systems North America Co. (2006) Summary page 2.
- (no number) syngo Dynamics: named in the summary without a submission number

## Most influential descendants
- K081018: Syngo Dynamics Version 7.0 (2008), 8 descendants of its own
- K102150: Syngo Dynamics, Version 9.0 (2010), 7 descendants of its own
- K123922: Syngo Dynamics (2013), 5 descendants of its own
- K171053: syngo Dynamics Version VA30 (2017), 4 descendants of its own
- K220832: syngo Dynamics (Version VA40E) (2022), 3 descendants of its own

## Recalls of this device
- Jul 23, 2008 · Not classified · Z-0545-2009: If the text is manually modified and additional phrases added as a result of worksheet interactions, some of the phrases may not populate the report.
- Feb 8, 2008 · Not classified · Z-1751-2008: Incorrect data: A software bug may result in a transfer of patient demographic data to a different patient's file.

## Indications for use
syngo® Dynamics is a Picture Archiving and Communication System (PACS) intended for acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation. syngo® Dynamics is not intended to be used for reading of mammography images.

Source page: https://510kreport.com/device/K070322
Methodology: https://510kreport.com/methodology