510(k) · Cleared
ClearedBrachytherapy Source Device, Model 9011
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medi-Physics, Inc., Dba GE Healthcare · IWG Seed, Isotope, Gold, Titanium, Platinum
Cleared on May 5, 2008 as substantially equivalent to K914281 (Medi-Physics Inc. Dba Nycomed Amersham Imaging, 1991) after a 20-day review. Its family tree reaches back 1 generation to 1991.
- Decided
- May 5, 2008
- Review
- 20 days
- Class
- Class II
- Product code
- IWG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K914281 (1991). No later device cites it as a predicate yet.
- Root · 1 generation backK914281 I-125 Seeds, Code: 6711Medi-Physics Inc. Dba Nycomed Amersham Imaging · 1991
- This deviceK081066 Brachytherapy Source Device, Model 9011Medi-Physics, Inc., Dba GE Healthcare · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K914281 | I-125 Seeds, Code: 6711 | Medi-Physics Inc. Dba Nycomed Amersham Imaging | 1991 | — |
| 0 (this device) | K081066 | Brachytherapy Source Device, Model 9011 | Medi-Physics, Inc., Dba GE Healthcare | 2008 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in IWG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K914281 | I-125 Seeds, Code: 6711Summary page 1…Class: II Classification: 21 CFR 892.5730 Product Code: 90-KXK Cleared 5 10(k) No.: K91428 1, FDA Cleared on November 22, 1991 Submitted by: Medi-Physics Inc, dba GE Healthcare… | 1991 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 11 other devices also cite its predicate K914281.
How does its category compare?
All IWG devicesIWG Seed, Isotope, Gold, Titanium, Platinum: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · IWG
1in 2008
2026 to Oct 25, outlined.
Median 510(k) review, days · IWG
Too few IWG 510(k)s in any year since 2007 to give a median.
Recalls per year · IWG
No recall names IWG since 2007.
Adverse event reports per year · IWG
1in 2010
MAUDE reports naming product code IWG, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (163 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081066 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081066: Brachytherapy Source Device, Model 9011.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081066
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026