# K962615: Tumorlocalizer Mri

- Pathway: 510(k) (Traditional)
- Applicant: Ferguson Medical
- Decided: Mar 19, 1998 after 624 days
- Product code: MIG (Strip, Test Isoniazid)
- Device class: U
- 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 K863090 (1986). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K863848: Manan Brest Tumor Localization Needle, Manan Manufacturing Co., Inc. (1986) Summary page 1.
- K914941: Simon Breast Lesion Localization Needle, Manan Medical Products, Inc. (1992) Summary page 1.
- K915417: Kopan's Target, Medical Device Technologies, Inc. (1992) Summary page 1.
- K863090: Percu Guide I (Loop Type), E-Z-Em, Inc. (1986) Summary page 1.
- K920816: Percuguide Lesion Marking, E-Z-Em, Inc. (1992) Summary page 1.

## Indications for use
The device is intended for use to mark or identify, by standard radiologic techniques (X-Ray, fluoroscopy, CT, MRI) the location of a soft tissue abnormality such as a cyst, lesion, or tumor.

Source page: https://510kreport.com/device/K962615
Methodology: https://510kreport.com/methodology