Clearance Summary
InstaRISPACS / InstaZFP / InstaMobi v5.0 received FDA 510(k) clearance under submission number K182572, sponsored by Meddiff Technologies Pvt. , Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2019-04-12.
- Submission: K182572
- Applicant / Sponsor: Meddiff Technologies Pvt. , Ltd.
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2050
- Decision date: 2019-04-12
Classification & Regulation
This clearance is catalogued under FDA product code LLZ and 21 CFR 892.2050, within the Radiology review panel as a Class II device.