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FDA 510(k)

IMAGE X-70 PLUS DENTAL X-RAY UNIT

K-Number: K000551 · 2000-03-16

ApplicantMedical Device Consultants, Inc.
Decision Date2000-03-16
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

IMAGE X-70 PLUS DENTAL X-RAY UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Medical Device Consultants, Inc.. It received FDA 510(k) clearance on 2000-03-16 under 510(k) number K000551. The device is classified under product code EHD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMAGE X-70 PLUS DENTAL X-RAY UNIT?

IMAGE X-70 PLUS DENTAL X-RAY UNIT is a medical device that received FDA 510(k) clearance on 2000-03-16. The listed applicant is Medical Device Consultants, Inc.. The 510(k) number is K000551.

When did IMAGE X-70 PLUS DENTAL X-RAY UNIT receive FDA 510(k) clearance?

IMAGE X-70 PLUS DENTAL X-RAY UNIT received FDA 510(k) clearance on 2000-03-16, under 510(k) number K000551.

Who is the listed applicant for IMAGE X-70 PLUS DENTAL X-RAY UNIT?

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

What is the FDA product code for IMAGE X-70 PLUS DENTAL X-RAY UNIT?

The FDA product code for IMAGE X-70 PLUS DENTAL X-RAY UNIT is EHD.

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Related Devices (Code: EHD)

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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