# K081066: Brachytherapy Source Device, Model 9011

- Pathway: 510(k) (Special)
- Applicant: Medi-Physics, Inc., Dba GE Healthcare
- Decided: May 5, 2008 after 20 days
- Product code: IWG (Seed, Isotope, Gold, Titanium, Platinum)
- 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: 1 generation back to K914281 (1991). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K914281: I-125 Seeds, Code: 6711, Medi-Physics Inc. Dba Nycomed Amersham Imaging (1991) Summary page 1.

## Indications for use
The Brachytherapy Source Device, with apparent activities between 0.19mCi and 1.01mCi, is indicated for permanent interstitial implantation of selected localized tumors which are of low to moderate radiosensitivity. They may be used either as primary treatment (such as for prostate cancer or unresectable tumors) or for treatment of residual disease after excision of the primary tumor. Seeds in this apparent activity range may be used to treat superficial, intra-abdominal, and intra-thoracic tumors. Tumors of the head, neck, lung, pancreas and prostate (early stages) are commonly treated. The Brachytherapy Source Device, with total apparent activities greater than 1.01mCi, is indicated for interstitial treatment of tumors which have the following characteristics; unresectable, localized, and moderate radiosensitivity. These seeds may be used for selected radiation applications as temporary implants. The Brachytherapy Source Device is indicated to treat residual tumors concurrent with or at the completion of other treatment modalities, such as external beam radiation therapy or chemotherapy. In addition, recurrent tumors may be implanted with seeds.

Source page: https://510kreport.com/device/K081066
Methodology: https://510kreport.com/methodology