Bullsai

510(k) Number

K241094 ↗

FDA product code

LLZ

FDA applicant

Turing Medical Technologies, Inc.

Device class

Class II

Regulation

21 CFR Part 892.2050

Advisory committee

Radiology

FDA decision

SESE Substantially Equivalent

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Source: 510k-lineage (choiben314), CC BY 4.0

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Other devices filed under FDA product code LLZ (System, Image Processing, Radiological).

• HCP DICOM NET by Softlink International, Inc.
• SCIVIEW SYSTEM, MODEL SC1250 AND PIXIE IMAGING SOF by Image Systems, Inc.
• MODELS PRIAM (FAMILY OF DEVICES) DIGITAL IMAGING SYSTEM by Hopkins Imaging Systems, Inc.
• HOLOSCOPE-i by Real View Imaging, Ltd.
• FX SPS by PIXEE MEDICAL
• Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert 16 by Cercare Medical A/S
• SYNAPSE 3D BASE TOOLS by Fujifilm Medical System U.S.A., Inc.
• Cleerly LABS by CLEERLY, INC
• CENTRICITY AW SUITE OPTION by Ge Healthcare Information Technologies
• Rology Teleradiology Platform (v.1.22.1103) by Rology, Inc.

• FIRMM® v5

  Class II

  FDA 510(k) K201141 Active Cleared 26 Aug 2020 GUDID on market

• Bullsai® Identify v2

  Class II

  FDA 510(k) K241094 Active Cleared 13 Aug 2024 GUDID on market

• Bullsai Confirm

  Class II

  FDA 510(k) K243520 Active Cleared 28 Mar 2025