# K021314: Sceptre-VS

- Pathway: 510(k) (Traditional)
- Applicant: Hitachi Medical Systems America, Inc.
- Decided: Jul 2, 2002 after 68 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: 1 generation back to K002782 (2000). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002782: Hermes HD AQ Acquisition Station and Hermes Workstation, Nuclear Diagnostics AB (2000) Summary page 1.

## Most influential descendants
- K042428: SCEPTREP3 Pet/CT (2004), 0 descendants of its own

## Indications for use
The intended use of the Sceptre-VS is to review, process, film and store multi-modality images acquired from other diagnostic imaging systems or workstations.

Source page: https://510kreport.com/device/K021314
Methodology: https://510kreport.com/methodology