# K242205: SpectoMed (v1.0)

- Pathway: 510(k) (Traditional)
- Applicant: Specto Medical
- Decided: Jan 14, 2025 after 172 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: 11 generations back to K924630 (1993). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222035: Avatar Medical Software V1, Avatar Medical (2023) Summary page 5.

## Indications for use
SpectoMed (v1.0) provides real-time spatial-visualization of medical imaging allowing the manipulation, processing, review, analysis, communication and media interchange of multi-dimensional digital images of several modalities as defined by the DICOM standard, such as CT or MRI imaging datasets. Furthermore, SpectoMed (v1.0) aids the clinician in the preparation of a surgical intervention with measurements and import of compatible objects within the realistic spatial visuals of the patient's anatomy as well as their intraoperative display. SpectoMed (v1.0) is intended as an aid for assessing patient images.

Source page: https://510kreport.com/device/K242205
Methodology: https://510kreport.com/methodology