# K001947: T.I.M.S., Version 2.00

- Pathway: 510(k) (Traditional)
- Applicant: Total Medical Information Management Systems, Inc.
- Decided: Nov 22, 2000 after 149 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: 2 generations back to K922164 (1993). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973959: Olicon Imaging Systems, Inc. 02-Workstation and/or Pacsview Software, Olicon Imaging Systems, Inc. (1997) Summary page 1.
- K896095: Images-on-Call Teleradiology System, Devices & Services Co. (1990) Summary page 1.

## Indications for use
TLM.S. receives image data, acquired from various sources, including but not limited to CT, MR, US, Nuclear, digital angiography and flourography, secondary capture devices (frame grabbers), scanners (digitizers) or other imaging sources. Images and data can be viewed, stored, transmitted (communicated), processed at the workstation, physician's desktop or other clinical application and distributed across networks or the worldwide web for viewing.

Source page: https://510kreport.com/device/K001947
Methodology: https://510kreport.com/methodology