Radassist
FDA 510(k) K934566 · Diacor, Inc.
510(k) numberK934566
Submission
- Device name
- Radassist
- Applicant
- Diacor, Inc.
Salt Lake City, UT, US - Received
- September 21, 1993
- Decision date
- November 3, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K930246 | MammorxIYE · Traditional | 07/26/1993SE |
| K893398 | Centralite BackpointerIWE · Traditional | 08/17/1989SE |
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| K860193 | PortalcastIXI · Traditional | 01/30/1986SE |
Questions and answers
When was Radassist cleared by the FDA?
Radassist (K934566) received a 510(k) decision of Substantially Equivalent on November 3, 1993, 43 days after the submission was received.
What is the product code of K934566?
The FDA product code is IYE – Accelerator, Linear, Medical, a Class II (moderate risk) device regulated under 21 CFR 892.5050.