Cleared Traditional

TeleScan (K233634) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K233634 · Bb Imaging · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2023
Decision
29d
Days
Class 2
Risk

K233634 is an FDA 510(k) clearance for the TeleScan. Classified as System, Image Processing, Radiological within the LLZ classification (a category encompassing advanced image processing and PACS-adjacent software), Class II - Special Controls.

Submitted by Bb Imaging (Austin, US). The FDA issued a Cleared decision on December 12, 2023 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Incremental AI imaging tool. Moderate equivalence dependency. Overall, this clearance reflects a predicate-aligned approval typical of modern AI radiology extensions - not a novel clinical breakthrough, but a validated iteration within an established regulatory category.

View all Bb Imaging devices

Submission Details

510(k) Number K233634 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2023
Decision Date December 12, 2023
Days to Decision 29 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 107d · This submission: 29d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code LLZ System, Image Processing, Radiological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Consultant

Regulatory Technology Services, LLC
Prithul Bom

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LLZ System, Image Processing, Radiological

All 797
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K233634.
syngo Application Software
K230955 · Siemens Medical Solutions USA, Inc. · Dec 2023
uOmnispace.MI
K233176 · Shanghai United Imaging Healthcare Co., Ltd. · Dec 2023
StrokeViewer Perfusion
K231570 · Nico-Lab B.V. · Dec 2023
DTX Studio Clinic (4.0)
K231898 · Nobel Biocare AB · Dec 2023
Myocardial Strain Software Application
K232661 · Circle Cardiovascular Imaging · Dec 2023
TraumaCad Neo
K231498 · Brainlab , Ltd. · Nov 2023