# K984167: SAGE 7

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems
- Decided: Jan 12, 1999 after 53 days
- Product code: LNI (System, Nuclear Magnetic Resonance Spectroscopic)
- 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
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 its predicate without a number.
- (no number) SA/GE Analysis option: named in the summary without a submission number
- (no number) SA/GE Spectroscopy option: named in the summary without a submission number

## Indications for use
SAGE 7 is a package of software tools for MR spectroscopic data processing and display. SAGE 7 is indicated for use for a wide variety of MR spectroscopic data management tasks, including file handling, display, processing/modeling, analysis, storage and hard copy output. The resultant spectroscopic presentations, when interpreted by a trained physician, can provide physiological / chemical information that can be useful in determining a diagnosis.

Source page: https://510kreport.com/device/K984167
Methodology: https://510kreport.com/methodology