Clearance Summary
CX 250 C PLUS WITH GAMMAXP SOFTWARE, MODEL 0121 0000 received FDA 510(k) clearance under submission number K052473, sponsored by Inter Medical Medizintechnik GmbH. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2005-10-28.
- Submission: K052473
- Applicant / Sponsor: Inter Medical Medizintechnik GmbH
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.1100
- Decision date: 2005-10-28
Classification & Regulation
This clearance is catalogued under FDA product code IYX and 21 CFR 892.1100, within the Radiology review panel as a Class I device.