Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Rology Teleradiology Platform (v.1.22.1103)

K-Number: K231385 · 2023-09-20

ApplicantRology, Inc.
Decision Date2023-09-20
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Rology Teleradiology Platform (v.1.22.1103) is a medical device manufactured by Rology, Inc.. It received FDA 510(k) clearance on 2023-09-20 under approval number K231385. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Rology Teleradiology Platform (v.1.22.1103)?

Rology Teleradiology Platform (v.1.22.1103) is a medical device that received FDA 510(k) clearance on 2023-09-20. It is manufactured by Rology, Inc.. The 510(k) number is K231385.

When was Rology Teleradiology Platform (v.1.22.1103) approved by the FDA?

Rology Teleradiology Platform (v.1.22.1103) received FDA 510(k) clearance on 2023-09-20, under approval number K231385.

What company makes Rology Teleradiology Platform (v.1.22.1103)?

Rology Teleradiology Platform (v.1.22.1103) is manufactured by Rology, Inc..

What is the FDA product code for Rology Teleradiology Platform (v.1.22.1103)?

The FDA product code for Rology Teleradiology Platform (v.1.22.1103) is LLZ.

Related Devices (Code: LLZ)

K161959ClearView cCADClearview Diagnostics, Inc. K163539Ez3D-i / E3Ewoosoft Co., Ltd. K162955Multi-Modality Tumor Tracking (MMTT) applicationPhilips Medical Systems Nederland B.V. K160852ZiaZetta Medical Technologies, LLC K162376CAAS MR 4D FlowPie Medical Imaging BV K161322CT CoPilotZepmed, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑