# K223290: CommandEP Data Manager PC (DPC02), CommandEP HMD (HMD02)

- Pathway: 510(k) (Traditional)
- Applicant: Sentiar, Inc.
- Decided: Jul 14, 2023 after 261 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)
- K192890: SentEP, Sentiar, Inc. (2020) Summary page 4.

## Indications for use
CommandEP is intended for use as a medical imaging system that allows the review, analysis, communication, and media interchange of multi-dimensional digital images. It is also intended for intraprocedural use. CommandEP is designed as an additional visualization modality to assist the clinician. CommandEP indicated for use in electrophysiology (EP) procedures to assist the clinician in visualization of the heart electroanatomic data.

Source page: https://510kreport.com/device/K223290
Methodology: https://510kreport.com/methodology