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FDA 510(k)

1.5` FOCAL SPOT RESOLUTION PATTERN

K-Number: K810254 · 1981-02-19

ApplicantMachlett Laboratories, Inc.
Decision Date1981-02-19
Product CodeIXF
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

1.5` FOCAL SPOT RESOLUTION PATTERN is the device name listed in this FDA 510(k) record. The listed applicant is Machlett Laboratories, Inc.. It received FDA 510(k) clearance on 1981-02-19 under 510(k) number K810254. 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 1.5` FOCAL SPOT RESOLUTION PATTERN?

1.5` FOCAL SPOT RESOLUTION PATTERN is a medical device that received FDA 510(k) clearance on 1981-02-19. The listed applicant is Machlett Laboratories, Inc.. The 510(k) number is K810254.

When did 1.5` FOCAL SPOT RESOLUTION PATTERN receive FDA 510(k) clearance?

1.5` FOCAL SPOT RESOLUTION PATTERN received FDA 510(k) clearance on 1981-02-19, under 510(k) number K810254.

Who is the listed applicant for 1.5` FOCAL SPOT RESOLUTION PATTERN?

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

What is the FDA product code for 1.5` FOCAL SPOT RESOLUTION PATTERN?

The FDA product code for 1.5` FOCAL SPOT RESOLUTION PATTERN is IXF.

Related Clinical Trials

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.

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Other records listing Machlett Laboratories, 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.

K813158RDP-2000K802888RAYTHEON MEDICAL IMAGINGK780969GAMMA CAMERA

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.K834482TISSUE MIMICKING ULTRASOUND PHANTOMSRadiation Measurements, Inc.K834481DOPPLER PHANTOM FLOW CONTROL SYSRadiation Measurements, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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