# K981398: Anatomark Noninvasive Head Reference System

- Pathway: 510(k) (Traditional)
- Applicant: Interneuron Pharmaceuticals, Inc.
- Decided: Jun 1, 1998 after 45 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- 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 K881131 (1988). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K881131: The Laitinen Stereotactic System, Sandstrom Trade & Technology, Inc. (1988) Summary page 1.
- K953568: Codman Fiducial Marker System, Codman & Shurtleff, Inc. (1996) Summary page 1.

## Indications for use
The AnatoMark Noninvasive Head Reference System is an accessory for routine head MR that is designed to provide reproducible anatomical markers. The Head Reference System is designed to aid in patient positioning to achieve consistent anatomical images over multiple imaging sessions. The head localizer produces a set of six fiduciary marks on axial images that are positioned reproducibly with reference to stable anatomical structures internal to the patient’s cranium. The fiduciary marks are also visible in CT images, making possible the co-registration of CT and MR images.

Source page: https://510kreport.com/device/K981398
Methodology: https://510kreport.com/methodology