LCM-2-LINAC Couch-Mount System
FDA 510(k) K924632 · Radionics, Inc.
510(k) numberK924632
Submission
- Device name
- LCM-2-LINAC Couch-Mount System
- Applicant
- Radionics, Inc.
Burlington, MA, US - Received
- September 14, 1992
- Decision date
- April 7, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was LCM-2-LINAC Couch-Mount System cleared by the FDA?
LCM-2-LINAC Couch-Mount System (K924632) received a 510(k) decision of Substantially Equivalent on April 7, 1993, 205 days after the submission was received.
What is the product code of K924632?
The FDA product code is IYE – Accelerator, Linear, Medical, a Class II (moderate risk) device regulated under 21 CFR 892.5050.