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FDA 510(k)

DR LONG LENGTH IMAGING SOFTWARE

K-Number: K130567 · 2013-06-11

ApplicantCarestream Health, Inc.
Decision Date2013-06-11
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DR LONG LENGTH IMAGING SOFTWARE is the device name listed in this FDA 510(k) record. The listed applicant is Carestream Health, Inc.. It received FDA 510(k) clearance on 2013-06-11 under 510(k) number K130567. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DR LONG LENGTH IMAGING SOFTWARE?

DR LONG LENGTH IMAGING SOFTWARE is a medical device that received FDA 510(k) clearance on 2013-06-11. The listed applicant is Carestream Health, Inc.. The 510(k) number is K130567.

When did DR LONG LENGTH IMAGING SOFTWARE receive FDA 510(k) clearance?

DR LONG LENGTH IMAGING SOFTWARE received FDA 510(k) clearance on 2013-06-11, under 510(k) number K130567.

Who is the listed applicant for DR LONG LENGTH IMAGING SOFTWARE?

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

What is the FDA product code for DR LONG LENGTH IMAGING SOFTWARE?

The FDA product code for DR LONG LENGTH IMAGING SOFTWARE is MQB.

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Related Devices (Code: MQB)

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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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