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FDA 510(k)

MODEL MGB-301 DIAPHRAGM FILM 24 X 30 CM

K-Number: K912180 · 1991-10-21

ApplicantInstrumentarium Imaging, Inc.
Decision Date1991-10-21
Product CodeIZX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MODEL MGB-301 DIAPHRAGM FILM 24 X 30 CM is the device name listed in this FDA 510(k) record. The listed applicant is Instrumentarium Imaging, Inc.. It received FDA 510(k) clearance on 1991-10-21 under 510(k) number K912180. The device is classified under product code IZX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL MGB-301 DIAPHRAGM FILM 24 X 30 CM?

MODEL MGB-301 DIAPHRAGM FILM 24 X 30 CM is a medical device that received FDA 510(k) clearance on 1991-10-21. The listed applicant is Instrumentarium Imaging, Inc.. The 510(k) number is K912180.

When did MODEL MGB-301 DIAPHRAGM FILM 24 X 30 CM receive FDA 510(k) clearance?

MODEL MGB-301 DIAPHRAGM FILM 24 X 30 CM received FDA 510(k) clearance on 1991-10-21, under 510(k) number K912180.

Who is the listed applicant for MODEL MGB-301 DIAPHRAGM FILM 24 X 30 CM?

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

What is the FDA product code for MODEL MGB-301 DIAPHRAGM FILM 24 X 30 CM?

The FDA product code for MODEL MGB-301 DIAPHRAGM FILM 24 X 30 CM is IZX.

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Other records listing Instrumentarium Imaging, Inc. as applicant

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Related Devices (Code: IZX)

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.

K110856RALCORalco S.R.L.K101036SHIMADZU COLLIMATOR R-20JShimadzu Corp.K042840SHIMADZU COLLIMATOR R-20JShimadzu Corp.K031771SHIMADZU COLLIMATOR R-30HShimadzu Corp.K981267FACTS MONOBLOCKDynarad Corp.K974240LIGHTLINE-MWuestec Medical, 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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