510(k) K213776
- Device
- LiverSmart
- Applicant
- Resonance Health Analysis Services Pty Ltd
- 510(k) number
- K213776
- Product code
- PCS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-12-29
- Date received
- 2021-12-02
- Regulation
- 892.1001
- Classification name
- Liver Iron Concentration Imaging Companion Diagnostic For Deferasirox
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Mitchell Wells
- Address
- 141 Burswood Rd. Perth AU 6100 6100
FDA Registration Numbers#
- 3005450718
Source Documents#
Other 510(k) Records For Product Code PCS #
Legacy Summary#
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FDA Review#
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