# K994317: I-Plant, Model 3500

- Pathway: 510(k) (Traditional)
- Applicant: Implant Sciences Corp.
- Decided: Mar 21, 2000 after 90 days
- Product code: KXK (Source, Brachytherapy, Radionuclide)
- Device class: 2
- Regulation: 21 CFR 892.5730
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K914281 (1991). 6 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990193: Iodine Brachytherapy Seeds, Model 3000, Implant Sciences Corp. (1999) Summary page 1.
- K914281: I-125 Seeds, Code: 6711, Medi-Physics Inc. Dba Nycomed Amersham Imaging (1991) Summary page 1.

## Most influential descendants
- K090366: Spec Model M-31 (2009), 1 descendant of its own
- K141038: Ant Model 1 (2014), 0 descendants of its own

## Indications for use
The Implant Sciences ' lodine Brachytherapy Seeds with activities from 0.1 to 5.0 mCi are indicated for temporary or permanent interstitial or intracavity implantation or surface application to treat selected localized tumors. They can be used either as primary treatment (such as for prostate cancer or unresectable tumors) or as treatment for residual disease after excision of primary or recurrent tumors. The ' |odine Seeds may be used concurrently with or following treatment with other interventions, such as external beam therapy, hyperthermia or chemotherapy. Tumors of the head, neck, lung, pancreas, prostate and other accessible tumors are commonly treated.

Source page: https://510kreport.com/device/K994317
Methodology: https://510kreport.com/methodology