# K070426: Silhouette, Model 1000.01

- Pathway: 510(k) (Traditional)
- Applicant: Aranz Medical Limited
- Decided: Jun 29, 2007 after 136 days
- Product code: FXN (Tape, Camera, Surgical)
- Device class: 1
- Regulation: 21 CFR 878.4160
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 1 cites it directly.
0 of 6 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) Verge Videometer: named in the summary without a submission number
- (no number) Visitrak: named in the summary without a submission number

## Most influential descendants
- K131596: Wound Measuring & Monitoring Device (2013), 4 descendants of its own
- K251678: Swift Ray 1 (2026), 0 descendants of its own
- K251255: LymphaTech Mobile 3D Measuring Tool (2025), 0 descendants of its own
- K230734: Multispectral Imager Kit (MSI Kit) (300-00015), Multispectral Imager (MSI) (300-00009) (2023), 0 descendants of its own
- K190074: Presero 3D Scanning System (2019), 0 descendants of its own

## Indications for use
Silhouette is indicated for wound measurement and documentation and can be used on all external wound types.

Source page: https://510kreport.com/device/K070426
Methodology: https://510kreport.com/methodology