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510(k) Data Aggregation

K Number

K992963

Device Name

I3RAD 125 I BRACHYTHERAPY SEED, MODEL I125-0401

Manufacturer

INTERNATIONAL ISOTOPES, INC.

Date Cleared

1999-09-21

(19 days)

Product Code

KXK

Regulation Number

892.5730

Intended Use

I3RAD 1351 Seeds with activities from 0.1 to 1.0 mCi are indicated for permanent interstitial implantation in selected localized tumors. They can be used either as primary treatment (such as prostate cancer or unresectable tumors) or treatment of residual disease after excision of the primary tumor or recurring turnors. They may also be used at completion of external beam radiation therapy. Tumors of the head, neck, lung, pancreas, breast, prostate (early stages), and other accessible tumors are commonly treated.

Device Description

The I3RAD. 1251 Seeds use 1251 beads encapsulated in a titanium tube.

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K Number

K982421

Device Name

IMAGYN 125 I SEED, MODEL IS 125

Manufacturer

INTERNATIONAL ISOTOPES, INC.

Date Cleared

1998-07-31

(18 days)

Product Code

IWG

Regulation Number

892.5730

Intended Use

Imagyn 125I Seeds with activities from 0.1 to 1.0 mCi are indicated for permanent interstitial implantation in selected localized tumors. They can to be used either as primary treatment (such as prostate cancer or unresectable tumors) or treatment for residual disease after excision of the primary tumor or recurring tumors. Tumors of the head, neck, lung, pancreas, prostate (early stages), and other accessible tumors are commonly treated.

Device Description

The Imagyn 125I Seeds use 125I beads encapsulated in a titanium tube.

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