# K153284: Synaptive ImageDrive Pro

- Pathway: 510(k) (Traditional)
- Applicant: Synaptive Medical, Inc.
- Decided: Mar 29, 2016 after 138 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K942120 (1994). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123174: Centricity Pacs-IW with Universal Viewer, GE Healthcare (2012) Summary page 4.

## Recalls of this device
- Feb 26, 2020 · Class II · Z-1759-2020: A software defect negatively affects the quality of images taken during diagnostic imaging (mammograms) which may result in misdiagnosis.

## Indications for use
Synaptive ImageDrive Pro is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed within the system or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Megapixel resolution and meet other technical specifications reviewed and accepted by the FDA. Typical users of this system are trained professionals, including but not limited to radiologists, physicians, nurses, medical technicians, and assistants.

Source page: https://510kreport.com/device/K153284
Methodology: https://510kreport.com/methodology