# K963860: The Nomos Talon Positioning and Immobilization System

- Pathway: 510(k) (Traditional)
- Applicant: Nomos Corp.
- Decided: Dec 23, 1996 after 88 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K901670 (1990). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K912630: Xknife Radiosurgery System, Rsa, Inc. (1991) Summary page 1.
- K923522: Linac-Based Sterotactic Radiosurgery, Radionics Software Applications, Inc. (1993) Summary page 1.
- K930279: Refix (TM) System, Nomos Corp. (1993) Summary page 1.
- K901670: Gnomos Stereotactic Device, Medical Equipment Development Co., Inc. (1990) Summary page 1.

## Cited in the summary but kept off the family tree
- K811452: Brown-Roberts-Wells Stereotaxic Sytem, Trent Wells, Inc. (1981). Our OCR of the scanned summary read K811452, FDA’s number for Brown-Roberts-Wells Stereotaxic Sytem (Trent Wells, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “RSA XKnife Radiosurgical System/BRW Stereotactic System”. Kept off the family tree. Summary page 1.

## Indications for use
The NOMOS TALON Positioning and immobilization System is intended to provide an invasive means to repeatedly position and immobilize a patient during: a) diagnostic procedures in preparation for radiation therapy (RT) treatments of the head or head and neck, and b) during treatment procedures in the radiation therapy suite.

Source page: https://510kreport.com/device/K963860
Methodology: https://510kreport.com/methodology