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FDA 510(k)

ACCULMAING

K-Number: K102849 · 2010-11-23

Decision Date2010-11-23
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ACCULMAING is the device name listed in this FDA 510(k) record. The listed applicant is Radiology Information Systems, Inc.. It received FDA 510(k) clearance on 2010-11-23 under 510(k) number K102849. 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 ACCULMAING?

ACCULMAING is a medical device that received FDA 510(k) clearance on 2010-11-23. The listed applicant is Radiology Information Systems, Inc.. The 510(k) number is K102849.

When did ACCULMAING receive FDA 510(k) clearance?

ACCULMAING received FDA 510(k) clearance on 2010-11-23, under 510(k) number K102849.

Who is the listed applicant for ACCULMAING?

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

What is the FDA product code for ACCULMAING?

The FDA product code for ACCULMAING is LLZ.

Related Clinical Trials

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.

Other records listing Radiology Information Systems, 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.

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.

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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