Siemens Mevatron Me
FDA 510(k) K852907 · Siemens Medical Laboratories, Inc.
510(k) numberK852907
Submission
- Device name
- Siemens Mevatron Me
- Applicant
- Siemens Medical Laboratories, Inc.
Walnut Creek, CA, US - Received
- July 9, 1985
- Decision date
- September 19, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K220883 | Small Field ApplicatorLHN · Traditional | Hitachi, Ltd. Radiation Oncology Systems… | 12/15/2022SE |
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| K875272 | Sonoline CFDXK · Traditional | 02/18/1988SE |
| K862339 | Mevatron KD-2IYE · Traditional | 10/29/1986SE |
| K854609 | Mevamatic 3JAD · Traditional | 02/21/1986SE |
| 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 Siemens Mevatron Me cleared by the FDA?
Siemens Mevatron Me (K852907) received a 510(k) decision of Substantially Equivalent on September 19, 1985, 72 days after the submission was received.
What is the product code of K852907?
The FDA product code is LHN – System, Radiation Therapy, Charged-Particle, Medical, a Class II (moderate risk) device regulated under 21 CFR 892.5050.