# K962792: Linac Scalpel Treatment Planning System

- Pathway: 510(k) (Traditional)
- Applicant: Surgical Navigation Technologies, Inc.
- Decided: Nov 12, 1996 after 118 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Recalls of this device
- Jan 30, 2012 · Not classified · Z-1217-2012: An anomaly has been identified with the CT Localization module of the FastPlan treatment planning system. If the module reports a significant difference in tilt or spin on a slice and the use elects t
- Mar 23, 2010 · Not classified · Z-0836-2011: Due to software Issue, an error occurs when performing cone planning using MRI, which may result in the patient receiving a higher radiation dose than expected, potentially to healthy tissue.
- May 29, 2008 · Not classified · Z-2195-2008: Due to issues with image orientation verification, a patient may receive all or some of prescribed high dose to healthy tissue instead of intended area.

## Indications for use
The LINAC Scalpel Treatment Planning System is intended as a aid in quickly and precisely planning the radiation treatment of small cranial lesions such as arteriovenons malformations. pituitary tumors. pincalomas. acoustic nenromas and malignant neoplasnis.

Source page: https://510kreport.com/device/K962792
Methodology: https://510kreport.com/methodology