K242205
- 510(k) number
- K242205
- Device name
- SpectoMed (v1.0)
- Applicant
- Specto Medical CH
- Product code
- LLZ — System, Image Processing, Radiological
- Decision date
- 2025-01-14
- Date received
- 2024-07-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
510(k) Summary (official FDA PDF): K242205.pdf
Official FDA record: K242205
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.