# K022788: Philips Harmony Release 1

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems North America Co.
- Decided: Oct 25, 2002 after 64 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: 3 generations back to K954479 (1996). 5 ancestors in all.
129 later devices descend from it; 1 cites it directly.
0 of 135 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K994210: Inturis Suite, Philips Medical Systems, Inc. (2000) Summary page 3.
- K954668: HP Echo Image Management System, Hewlett-Packard Co. (1995) Summary page 3.

## Most influential descendants
- K061995: Xcelera (2006), 128 descendants of its own
- K083348: Image-Arena Applications (2008), 89 descendants of its own
- K090461: Image-Arena 4.0 and IA Applications 2D Cardiac Performance Analysis 1.0 (2009), 86 descendants of its own
- K120135: 2D Cardiac Performance Analysis MR 1.0 (2012), 82 descendants of its own
- K110746: 4D LV-Analysis 3.0 (2011), 80 descendants of its own

## Recalls of this device
- Dec 21, 2004 · Not classified · Z-0640-05: Loss of image data from image repository and archive requiring patients to undergo repeat imaging.
- Apr 15, 2004 · Not classified · Z-0973-04: Potential for the image data to be erased from the long term archive.

## Indications for use
“Harmony”, is a suite of products comprised out of scalable levels of modular software programs, designed to perform the necessary functions required for the import, export, storage, archiving, review, analysis, reporting and database management of multimodality digital medical images. ‘‘Harmony” software will run on Intel based commercial hardware under Microsoft Windows based operating systems.

Source page: https://510kreport.com/device/K022788
Methodology: https://510kreport.com/methodology