Extracranial Radiotherapy System
FDA 510(k) K982463 · Howmedica, Inc.
510(k) numberK982463
Submission
- Device name
- Extracranial Radiotherapy System
- Applicant
- Howmedica, Inc.
Rutherford, NJ, US - Received
- July 15, 1998
- Decision date
- September 30, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Extracranial Radiotherapy System cleared by the FDA?
Extracranial Radiotherapy System (K982463) received a 510(k) decision of Substantially Equivalent on September 30, 1998, 77 days after the submission was received.
What is the product code of K982463?
The FDA product code is IYE – Accelerator, Linear, Medical, a Class II (moderate risk) device regulated under 21 CFR 892.5050.