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FDA 510(k)

MODELS PRIAM (FAMILY OF DEVICES) DIGITAL IMAGING SYSTEM

K-Number: K000630 · 2000-05-12

ApplicantHopkins Imaging Systems, Inc.
Decision Date2000-05-12
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MODELS PRIAM (FAMILY OF DEVICES) DIGITAL IMAGING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Hopkins Imaging Systems, Inc.. It received FDA 510(k) clearance on 2000-05-12 under 510(k) number K000630. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODELS PRIAM (FAMILY OF DEVICES) DIGITAL IMAGING SYSTEM?

MODELS PRIAM (FAMILY OF DEVICES) DIGITAL IMAGING SYSTEM is a medical device that received FDA 510(k) clearance on 2000-05-12. The listed applicant is Hopkins Imaging Systems, Inc.. The 510(k) number is K000630.

When did MODELS PRIAM (FAMILY OF DEVICES) DIGITAL IMAGING SYSTEM receive FDA 510(k) clearance?

MODELS PRIAM (FAMILY OF DEVICES) DIGITAL IMAGING SYSTEM received FDA 510(k) clearance on 2000-05-12, under 510(k) number K000630.

Who is the listed applicant for MODELS PRIAM (FAMILY OF DEVICES) DIGITAL IMAGING SYSTEM?

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

What is the FDA product code for MODELS PRIAM (FAMILY OF DEVICES) DIGITAL IMAGING SYSTEM?

The FDA product code for MODELS PRIAM (FAMILY OF DEVICES) DIGITAL IMAGING SYSTEM is LLZ.

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Related Devices (Code: LLZ)

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

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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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