# K981213: Universal Instrument Registration (Uir) Microscope Module I

- Pathway: 510(k) (Traditional)
- Applicant: Radionics, Inc.
- Decided: Jul 1, 1998 after 90 days
- Product code: HAW (Neurological Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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) Zeiss Surgical Microscope Navigator (SMN) and Surgical Tool Navigator (STN): named in the summary without a submission number

## Most influential descendants
- K990326: Optical Tracking System Microscope Module II, Model Ots Mmii (1999), 0 descendants of its own

## Indications for use
The system accessories are indicated for all cranial and spinal surgical procedures covered by the OTS where anatomical landmarks are not clearly visible or where a desired target is close to critical structures.

Source page: https://510kreport.com/device/K981213
Methodology: https://510kreport.com/methodology