# K993532: DDS, DS3000, RS3000, CS5000, OT3000, IS3000, RS5000, CD3000, US3000, (Amongst Other Names)

- Pathway: 510(k) (Traditional)
- Applicant: Impax Technology, Inc.
- Decided: Dec 15, 1999 after 57 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
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Radworks Medical Imagining Software with Quality Control Module: named in the summary without a submission number

## Most influential descendants
- K040344: Impax OT3000 Orthopedic Workstation (2004), 2 descendants of its own
- K042867: Philips Orthopaedic Applications (2004), 1 descendant of its own
- K060210: Mediport (2006), 0 descendants of its own

## Indications for use
DDS software is combined with appropriate hardware to form a diagnostic review station. DDS is used to display and manipulate patient images and demographic information, for diagnostic, review and referral purposes. It is a software package which may be marketed as a software only solution, or in conjunction with standard hardware. DDS can be used as a stand-alone system or in connection with a larger system.

Source page: https://510kreport.com/device/K993532
Methodology: https://510kreport.com/methodology