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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 the device name listed in this FDA 510(k) record. The listed applicant is Rology, Inc.. It received FDA 510(k) clearance on 2023-09-20 under 510(k) 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. The listed applicant is Rology, Inc.. The 510(k) number is K231385.

When did Rology Teleradiology Platform (v.1.22.1103) receive FDA 510(k) clearance?

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

Who is the listed applicant for Rology Teleradiology Platform (v.1.22.1103)?

The FDA 510(k) record lists Rology, Inc. as the applicant. This does not by itself establish the device manufacturer.

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)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.

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