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FDA 510(k)

TISSUE MIMICKING ULTRASOUND PHANTOMS

K-Number: K834482 · 1984-01-25

ApplicantRadiation Measurements, Inc.
Decision Date1984-01-25
Product CodeIXF
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

TISSUE MIMICKING ULTRASOUND PHANTOMS is the device name listed in this FDA 510(k) record. The listed applicant is Radiation Measurements, Inc.. It received FDA 510(k) clearance on 1984-01-25 under 510(k) number K834482. The device is classified under product code IXF. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TISSUE MIMICKING ULTRASOUND PHANTOMS?

TISSUE MIMICKING ULTRASOUND PHANTOMS is a medical device that received FDA 510(k) clearance on 1984-01-25. The listed applicant is Radiation Measurements, Inc.. The 510(k) number is K834482.

When did TISSUE MIMICKING ULTRASOUND PHANTOMS receive FDA 510(k) clearance?

TISSUE MIMICKING ULTRASOUND PHANTOMS received FDA 510(k) clearance on 1984-01-25, under 510(k) number K834482.

Who is the listed applicant for TISSUE MIMICKING ULTRASOUND PHANTOMS?

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

What is the FDA product code for TISSUE MIMICKING ULTRASOUND PHANTOMS?

The FDA product code for TISSUE MIMICKING ULTRASOUND PHANTOMS is IXF.

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Other records listing Radiation Measurements, 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.

K893216RMI ULTRASOUND DOPPLER PHANTOM SYSTEMK885223RMI SHORT DISTANCE ALIGNMENT DEVICEK873956ULTIMETERK873836MAMMOGRAPHIC KVP METER MODEL 232K854976RMI RESPIRATORY GATING SYSTEM MODEL 301K834483DIGI-X

View all 12 devices →

Related Devices (Code: IXF)

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.

K865100TISSUE-EQUIVALENT BREAST SIMULATORComputerized Imaging Reference Systems, Inc.K851812DIGITAL SUBTRACTION ANTIOGRAPHY PHANTOM 76-700/711Victoreen, Inc.K834481DOPPLER PHANTOM FLOW CONTROL SYSRadiation Measurements, Inc.K8102541.5` FOCAL SPOT RESOLUTION PATTERNMachlett Laboratories, 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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