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FDA 510(k)

LORAD M-III ELITE (M-III E)

K-Number: K973631 · 1997-12-23

ApplicantLorad Corp.
Decision Date1997-12-23
Product CodeIZH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

LORAD M-III ELITE (M-III E) is the device name listed in this FDA 510(k) record. The listed applicant is Lorad Corp.. It received FDA 510(k) clearance on 1997-12-23 under 510(k) number K973631. The device is classified under product code IZH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LORAD M-III ELITE (M-III E)?

LORAD M-III ELITE (M-III E) is a medical device that received FDA 510(k) clearance on 1997-12-23. The listed applicant is Lorad Corp.. The 510(k) number is K973631.

When did LORAD M-III ELITE (M-III E) receive FDA 510(k) clearance?

LORAD M-III ELITE (M-III E) received FDA 510(k) clearance on 1997-12-23, under 510(k) number K973631.

Who is the listed applicant for LORAD M-III ELITE (M-III E)?

The FDA 510(k) record lists Lorad Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LORAD M-III ELITE (M-III E)?

The FDA product code for LORAD M-III ELITE (M-III E) is IZH.

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Other records listing Lorad Corp. 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.

K992280LORAD 1-650 (INTERNATIONAL 650)K974460LITE TOUCH ERBIUM LASER TREATMENT SYSTEMK952210LORAD STEROLOC IIK945241LORAD M-IV, LORAD M-IVIK950608DIGITAL SPOT MAMMOGRAPHY FOR STEROTACTIC APPLICATIONK945496MAMMOGRAPHIC X-RAY UNIT

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Related Devices (Code: IZH)

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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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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