TeleScan

FDA 510(k) K233634 · Bb Imaging

Substantially Equivalent

510(k) numberK233634

Submission

Device name
TeleScan
Applicant
Bb Imaging
Austin, TX, US
Received
November 13, 2023
Decision date
December 12, 2023
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA
Third-party review
Yes

Official FDA 510(k) record

Device classification

Product code
LLZ – System, Image Processing, Radiological
Device class
Class II (moderate risk)
Regulation
21 CFR 892.2050
Specialty
Radiology

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Questions and answers

When was TeleScan cleared by the FDA?

TeleScan (K233634) received a 510(k) decision of Substantially Equivalent on December 12, 2023, 29 days after the submission was received.

What is the product code of K233634?

The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.