K241318
- 510(k) number
- K241318
- Device name
- Nova Surface Applicator (ADPT-ONDEM-3DPRT-BRA)
- Applicant
- Adaptiiv Medical Technologies, Inc. CA
- Product code
- MUJ — System, Planning, Radiation Therapy Treatment
- Decision date
- 2024-08-30
- Date received
- 2024-05-10
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K241318.pdf
Official FDA record: K241318
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.