360 Deg. Rotating 1/2 Beam Block
FDA 510(k) K941719 · Medtec, Inc.
510(k) numberK941719
Submission
- Device name
- 360 Deg. Rotating 1/2 Beam Block
- Applicant
- Medtec, Inc.
Orange City, IA, US - Received
- April 7, 1994
- Decision date
- July 18, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was 360 Deg. Rotating 1/2 Beam Block cleared by the FDA?
360 Deg. Rotating 1/2 Beam Block (K941719) received a 510(k) decision of Substantially Equivalent on July 18, 1994, 102 days after the submission was received.
What is the product code of K941719?
The FDA product code is IXI – Block, Beam-Shaping, Radiation Therapy, a Class II (moderate risk) device regulated under 21 CFR 892.5710.