Radiation Bolus
FDA 510(k) K811528 · Action Products, Inc.
510(k) numberK811528
Submission
- Device name
- Radiation Bolus
- Applicant
- Action Products, Inc.
Mchenry, IL, US - Received
- June 1, 1981
- Decision date
- July 10, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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More from Icad, Inc.
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|---|---|---|
| K801694 | Flotation Pad for Operating TableFMP · Traditional | 08/27/1980SE |
Questions and answers
When was Radiation Bolus cleared by the FDA?
Radiation Bolus (K811528) received a 510(k) decision of Substantially Equivalent on July 10, 1981, 39 days after the submission was received.
What is the product code of K811528?
The FDA product code is JAD – System, Therapeutic, X-Ray, a Class II (moderate risk) device regulated under 21 CFR 892.5900.