TOMTEC-ARENA— 510(k) K213544
Substantially EquivalentTomtec Imaging Systems GmbH
FDA 510(k) clearance K213544 for TOMTEC-ARENA, Substantially Equivalent on 2022-01-06. Applicant: Tomtec Imaging Systems GmbH. Device class: 2.
Clearance details
- Applicant
- Tomtec Imaging Systems GmbH
- Product code
- Code QIH
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Unterschleissheim, DE
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