FDA 510(k)

TeleScan

K-Number: K233634 · 2023-12-12

Decision Date2023-12-12

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

TeleScan is the device name listed in this FDA 510(k) record. The listed applicant is Bb Imaging. It received FDA 510(k) clearance on 2023-12-12 under 510(k) number K233634. 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 TeleScan?

TeleScan is a medical device that received FDA 510(k) clearance on 2023-12-12. The listed applicant is Bb Imaging. The 510(k) number is K233634.

When did TeleScan receive FDA 510(k) clearance?

TeleScan received FDA 510(k) clearance on 2023-12-12, under 510(k) number K233634.

Who is the listed applicant for TeleScan?

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

What is the FDA product code for TeleScan?

The FDA product code for TeleScan is LLZ.

Other records listing Bb Imaging as applicant

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.

K220767TeleScan

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Official Source

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