Clearance Summary
AT&T IMAGE SOLUTIONS PICASSO STILL-IMAGE PHONE SYSTEM received FDA 510(k) clearance under submission number K944322, sponsored by At&T Image Solutions. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1995-02-24.
- Submission: K944322
- Applicant / Sponsor: At&T Image Solutions
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.2020
- Decision date: 1995-02-24
Classification & Regulation
This clearance is catalogued under FDA product code LMD and 21 CFR 892.2020, within the Radiology review panel as a Class I device.