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FDA 510(k)

SMART Bun-Yo-Matic X-Ray

K-Number: K240736 · 2024-07-02

ApplicantDisior, Ltd.
Decision Date2024-07-02
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SMART Bun-Yo-Matic X-Ray is the device name listed in this FDA 510(k) record. The listed applicant is Disior, Ltd.. It received FDA 510(k) clearance on 2024-07-02 under 510(k) number K240736. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SMART Bun-Yo-Matic X-Ray?

SMART Bun-Yo-Matic X-Ray is a medical device that received FDA 510(k) clearance on 2024-07-02. The listed applicant is Disior, Ltd.. The 510(k) number is K240736.

When did SMART Bun-Yo-Matic X-Ray receive FDA 510(k) clearance?

SMART Bun-Yo-Matic X-Ray received FDA 510(k) clearance on 2024-07-02, under 510(k) number K240736.

Who is the listed applicant for SMART Bun-Yo-Matic X-Ray?

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

What is the FDA product code for SMART Bun-Yo-Matic X-Ray?

The FDA product code for SMART Bun-Yo-Matic X-Ray is QIH.

Other records listing Disior, Ltd. 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.

K253764ENOS Software Guided External Fixation SystemK250023SMART PCFDK240642SMART Bun-Yo-Matic CTK223757BonelogicK203290Bonelogic

Related Devices (Code: QIH)

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.

K253794Prostate CoreLucida Medical, Ltd.K252571mdprostateMediaire GmbHK253902RealGUIDE3DIEMME SRLK253835AffinityHermes Medical Solutions ABK260980cmAngio® V2.0Curemetrix, Inc.K261210Cleerly PlaqueCleerly, Inc.

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.

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