# K032149: Rita Model 1500X Electrosurgical RF Generator

- Pathway: 510(k) (Traditional)
- Applicant: Rita Medical Systems, Inc.
- Decided: Sep 9, 2003 after 57 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
11 later devices descend from it; 1 cites it directly.
0 of 12 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) RITA Medical Systems Inc. - Model 1500X & Model 2500 Electrosurgical RF Generator: named in the summary without a submission number

## Most influential descendants
- K094009: Halt 2000GI Electrosurgical RF Ablation System Model Halt 2000GI (2010), 10 descendants of its own
- K121858: The Ablation System (2012), 9 descendants of its own
- K173703: Sonata Sonography-Guided Transcervical Fibroid Ablation System (2018), 6 descendants of its own
- K193516: Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1 (2020), 5 descendants of its own
- K211535: Sonata Transcervical Fibroid Ablation System 2.2 (2021), 4 descendants of its own

## Indications for use
The RITA® System (RF generator and electrosurgical devices) supplies energy for use in electrosurgery and is indicated for use in percutaneous, laparoscopic, or intraoperative coagulation and ablation of soft tissue, including: the partial or complete ablation of non-resectable liver lesions and the palliation of pain associated with metastatic lesions involving bone in patients who have failed or are not candidates for standard pain therapy.

Source page: https://510kreport.com/device/K032149
Methodology: https://510kreport.com/methodology