Mevamatic 3
FDA 510(k) K854609 · Siemens Medical Laboratories, Inc.
510(k) numberK854609
Submission
- Device name
- Mevamatic 3
- Applicant
- Siemens Medical Laboratories, Inc.
Walnut Creek, CA, US - Received
- November 18, 1985
- Decision date
- February 21, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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More from Icad, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K910971 | Z XT Radiation Therapy Treatment TableJAI · Traditional | 05/03/1991SE |
| K903139 | Beamview & Beamview Plus (Aka Project 743)IYE · Traditional | 11/07/1990SE |
| K894230 | Patient Data Management System (Project 735)IYE · Traditional | 08/28/1989SE |
| K882729 | Mevatron, M 2 ClassIYE · Traditional | 09/19/1988SE |
| K875272 | Sonoline CFDXK · Traditional | 02/18/1988SE |
| K862339 | Mevatron KD-2IYE · Traditional | 10/29/1986SE |
| K852907 | Siemens Mevatron MeLHN · Traditional | 09/19/1985SE |
| K812032 | Mevatron 67EIYE · Traditional | 08/18/1981SE |
| K791967 | Mevatron 74X Medical Linear AcceleratorIYE · Traditional | 11/16/1979SE |
| K790747 | Mevatron 74IYE · Traditional | 05/04/1979SE |
Questions and answers
When was Mevamatic 3 cleared by the FDA?
Mevamatic 3 (K854609) received a 510(k) decision of Substantially Equivalent on February 21, 1986, 95 days after the submission was received.
What is the product code of K854609?
The FDA product code is JAD – System, Therapeutic, X-Ray, a Class II (moderate risk) device regulated under 21 CFR 892.5900.