Mobil XR
FDA 510(k) K781705 · Siemens Corp.
510(k) numberK781705
Submission
- Device name
- Mobil XR
- Applicant
- Siemens Corp.
Mchenry, IL, US - Received
- October 10, 1978
- Decision date
- October 24, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Mobil XR cleared by the FDA?
Mobil XR (K781705) received a 510(k) decision of Substantially Equivalent on October 24, 1978, 14 days after the submission was received.
What is the product code of K781705?
The FDA product code is IZL – System, X-Ray, Mobile, a Class II (moderate risk) device regulated under 21 CFR 892.1720.