Clearance Summary
DCX-100 CHEST UNIT-GL-5000M received FDA 510(k) clearance under submission number K841923, sponsored by Transworld X-Ray Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1984-08-10.
- Submission: K841923
- Applicant / Sponsor: Transworld X-Ray Corp.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1680
- Decision date: 1984-08-10
Classification & Regulation
This clearance is catalogued under FDA product code KPR and 21 CFR 892.1680, within the Radiology review panel as a Class II device.