Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Bullsai

K-Number: K241094 · 2024-08-13

ApplicantTuring Medical Technologies, Inc.
Decision Date2024-08-13
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Bullsai is a medical device manufactured by Turing Medical Technologies, Inc.. It received FDA 510(k) clearance on 2024-08-13 under approval number K241094. 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 Bullsai?

Bullsai is a medical device that received FDA 510(k) clearance on 2024-08-13. It is manufactured by Turing Medical Technologies, Inc.. The 510(k) number is K241094.

When was Bullsai approved by the FDA?

Bullsai received FDA 510(k) clearance on 2024-08-13, under approval number K241094.

What company makes Bullsai?

Bullsai is manufactured by Turing Medical Technologies, Inc..

What is the FDA product code for Bullsai?

The FDA product code for Bullsai is LLZ.

Other Devices by Turing Medical Technologies, Inc.

K243520Bullsai Confirm

Related Devices (Code: LLZ)

K161959ClearView cCADClearview Diagnostics, Inc. K163539Ez3D-i / E3Ewoosoft Co., Ltd. K162955Multi-Modality Tumor Tracking (MMTT) applicationPhilips Medical Systems Nederland B.V. K160852ZiaZetta Medical Technologies, LLC K162376CAAS MR 4D FlowPie Medical Imaging BV K161322CT CoPilotZepmed, LLC

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.

↑