Clearance Summary
MODEL DH-1000 SINGLE DETEC./DUAL DETEC NUCL CAMERA received FDA 510(k) clearance under submission number K904050, sponsored by Philips Medical Systems (Cleveland), Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1990-12-05.
- Submission: K904050
- Applicant / Sponsor: Philips Medical Systems (Cleveland), Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.1100
- Decision date: 1990-12-05
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.