# K013574: Accent

- Pathway: 510(k) (Traditional)
- Applicant: Confirma, Inc.
- Decided: Jan 15, 2002 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
No predicates in its family tree.
18 later devices descend from it; 1 cites it directly.
0 of 19 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) Vital Images Vitrea: named in the summary without a submission number
- (no number) Acculmage Image Display Software: named in the summary without a submission number
- (no number) Siemens BOLD MRI: named in the summary without a submission number
- (no number) Voxar Plug n’ View 3D: named in the summary without a submission number

## Most influential descendants
- K041286: Dynacad V1.0 (2004), 17 descendants of its own
- K081556: Cadstream, Version 5.0 (2009), 9 descendants of its own
- K092954: Cadstream Version 5 (2009), 8 descendants of its own
- K170195: QuantX (2017), 4 descendants of its own
- K210670: BU-CAD (2021), 3 descendants of its own

## Indications for use
ACCENT™ is a computerized tissue segmentation device intended for use in conjunction with magnetic resonance (MRI) imaging data to identify similar tissue types. When interpreted by a skilled physician, this device provides information that may be useful in screening and diagnosis. ACCENT can also be used to provide accurate and reproducible measurements of the longest diameter and volume of identified tissue. Patient management decisions should not be made based solely on the results of ACCENT analysis.

Source page: https://510kreport.com/device/K013574
Methodology: https://510kreport.com/methodology