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FDA 510(k)

COMPUTERIZED AXIAL TOMOGRAPHY

K-Number: K780995 · 1978-06-22

ApplicantEmi Medical, Inc.
Decision Date1978-06-22
Product CodeIZF
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

COMPUTERIZED AXIAL TOMOGRAPHY is the device name listed in this FDA 510(k) record. The listed applicant is Emi Medical, Inc.. It received FDA 510(k) clearance on 1978-06-22 under 510(k) number K780995. The device is classified under product code IZF. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COMPUTERIZED AXIAL TOMOGRAPHY?

COMPUTERIZED AXIAL TOMOGRAPHY is a medical device that received FDA 510(k) clearance on 1978-06-22. The listed applicant is Emi Medical, Inc.. The 510(k) number is K780995.

When did COMPUTERIZED AXIAL TOMOGRAPHY receive FDA 510(k) clearance?

COMPUTERIZED AXIAL TOMOGRAPHY received FDA 510(k) clearance on 1978-06-22, under 510(k) number K780995.

Who is the listed applicant for COMPUTERIZED AXIAL TOMOGRAPHY?

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

What is the FDA product code for COMPUTERIZED AXIAL TOMOGRAPHY?

The FDA product code for COMPUTERIZED AXIAL TOMOGRAPHY is IZF.

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Other records listing Emi Medical, 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.

K791429EMISONIC 4290K781936SCANNER-EMI 7020 AND 7020RK781519EMI SIMULATOR REMOTE CONTROL CONSOLEK781051EMISONIC 4201K780928CT5137 HIGH RESOLUTION OPTIONK7809305543 INDEPENDENT VIEWING SYSTEM

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Related Devices (Code: IZF)

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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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