# K092204: PMD Viewer

- Pathway: 510(k) (Traditional)
- Applicant: Spencer Technologies
- Decided: Oct 8, 2009 after 78 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 K934041 (1994). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022896: CSV12 Software Viewer, Acuson Corp. (2002) Summary page 1.
- K002533: TCD 100M, PWD13 Transducer, Spencer Technologies (2000) Summary page 1.

## Indications for use
The PMD Viewer Software is intended to provide off-line data viewing, playback, and report generation features of transcranial TCD100M/PMD150O Doppler ultrasound studies on a PC. PMD Viewer may only be operated independently, as a software-only product. PMD Viewer is intended for use by a technologist or physician trained in the use of Doppler ultrasound. PMD Viewer is NOT intended to replace any means of evaluating vital patient physiological processes. No new intended uses are claimed.

Source page: https://510kreport.com/device/K092204
Methodology: https://510kreport.com/methodology