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FDA 510(k)

MAG RES IMAG SYST/BRUKER MODEL R28 WHOLE BODY SCAN

K-Number: K913463 · 1991-11-29

ApplicantBruker Medical Imaging, Inc.
Decision Date1991-11-29
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MAG RES IMAG SYST/BRUKER MODEL R28 WHOLE BODY SCAN is the device name listed in this FDA 510(k) record. The listed applicant is Bruker Medical Imaging, Inc.. It received FDA 510(k) clearance on 1991-11-29 under 510(k) number K913463. 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 MAG RES IMAG SYST/BRUKER MODEL R28 WHOLE BODY SCAN?

MAG RES IMAG SYST/BRUKER MODEL R28 WHOLE BODY SCAN is a medical device that received FDA 510(k) clearance on 1991-11-29. The listed applicant is Bruker Medical Imaging, Inc.. The 510(k) number is K913463.

When did MAG RES IMAG SYST/BRUKER MODEL R28 WHOLE BODY SCAN receive FDA 510(k) clearance?

MAG RES IMAG SYST/BRUKER MODEL R28 WHOLE BODY SCAN received FDA 510(k) clearance on 1991-11-29, under 510(k) number K913463.

Who is the listed applicant for MAG RES IMAG SYST/BRUKER MODEL R28 WHOLE BODY SCAN?

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

What is the FDA product code for MAG RES IMAG SYST/BRUKER MODEL R28 WHOLE BODY SCAN?

The FDA product code for MAG RES IMAG SYST/BRUKER MODEL R28 WHOLE BODY SCAN is LNH.

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Other records listing Bruker Medical 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.

K915657MODIFIED MAGNETIC RESONANCE IMAGING SYTEM MOD. R28K903661BRUKER R-28,HEAD AND CHEST ANGIOGRAPHY IMAGING ADDK900026BRUKER R28 WHOLE-BODY MR SCANNERK895328MAGNETIC RESONANCE SYSTEM MODEL BMT-1100K8947141989 SOFTWARE REVISION TO THE BMT-1100K891760MAGNETIC RESONANCE SYSTEM, MODEL BMT 1100,MODIFIED

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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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