FDA 510(k)

DEL-IMS

K-Number: K063188 · 2006-11-30

Decision Date2006-11-30

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

DEL-IMS is the device name listed in this FDA 510(k) record. The listed applicant is Del Medical Imaging Corp.. It received FDA 510(k) clearance on 2006-11-30 under 510(k) number K063188. 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 DEL-IMS?

DEL-IMS is a medical device that received FDA 510(k) clearance on 2006-11-30. The listed applicant is Del Medical Imaging Corp.. The 510(k) number is K063188.

When did DEL-IMS receive FDA 510(k) clearance?

DEL-IMS received FDA 510(k) clearance on 2006-11-30, under 510(k) number K063188.

Who is the listed applicant for DEL-IMS?

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

What is the FDA product code for DEL-IMS?

The FDA product code for DEL-IMS is LLZ.

Other records listing Del Medical Imaging 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.

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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.