K121653 is an FDA 510(k) clearance for the INTRABEAM SYSTEM WITH INTRABEAM SPHERICAL APPLICATORS. Classified as System, Therapeutic, X-ray (product code JAD), Class II - Special Controls.
Submitted by Carl Zeiss Meditec, Inc. (Dublin, US). The FDA issued a Cleared decision on December 27, 2012 after a review of 205 days - an extended review cycle.
This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5900 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.
Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.
View all Carl Zeiss Meditec, Inc. devices
NCT00983684
Completed
Interventional
Comparison of Intra-operative Radiotherapy With Post-operative Radiotherapy for Women With Early Breast Cancer
TARGIT: A Randomised Controlled Trial to Compare Targeted Intra-operative Radiotherapy With Conventional Post-operative Radiotherapy After Conservative Breast Surgery for Women With Early Stage Breast Cancer
| Condition studied |
Invasive Breast Cancer; Breast Cancer |
| Study design |
Parallel |
| Eligibility |
Female only
· 45 Years+
|
| Principal investigator |
Jeffrey S Tobias, MD FRCP FRCR |
| Sponsor |
University College, London
|
Started 2000-03-01
→
Primary completion 2012-06-01
Primary outcome
Local relapse within the treated breast.
Secondary outcome
Site of relapse within the breast
Study completed - no results published.
This trial concluded in 2012 but has not posted
results to ClinicalTrials.gov. Completed studies without public results are common
in industry-sponsored device trials; the data may be referenced in the
510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov