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

FDA 510(k)

InVision™ 1.5 Surgical Theatre

K-Number: K240157 · 2024-02-15

ApplicantDeerfield Imaging, Inc.
Decision Date2024-02-15
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

InVision™ 1.5 Surgical Theatre is the device name listed in this FDA 510(k) record. The listed applicant is Deerfield Imaging, Inc.. It received FDA 510(k) clearance on 2024-02-15 under 510(k) number K240157. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the InVision™ 1.5 Surgical Theatre?

InVision™ 1.5 Surgical Theatre is a medical device that received FDA 510(k) clearance on 2024-02-15. The listed applicant is Deerfield Imaging, Inc.. The 510(k) number is K240157.

When did InVision™ 1.5 Surgical Theatre receive FDA 510(k) clearance?

InVision™ 1.5 Surgical Theatre received FDA 510(k) clearance on 2024-02-15, under 510(k) number K240157.

Who is the listed applicant for InVision™ 1.5 Surgical Theatre?

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

What is the FDA product code for InVision™ 1.5 Surgical Theatre?

The FDA product code for InVision™ 1.5 Surgical Theatre is LNH.

Other records listing Deerfield Imaging, Inc. 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.

K212367IMRIS iMRI 3T V

Related Devices (Code: LNH)

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.

K253808AIR Recon DLGE Medical SystemsK261331I-Genius (100019400)Esaote, S.p.A.K260852MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.PureSiemens Healthineers AGK260113uMR AstraShanghai United Imaging Healthcare Co., Ltd.K253862APERTO Lucent MRI SystemFujifilm CorporationK260746S-scan Open (100001800)Esaote, S.p.A.

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.

↑