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FDA 510(k)

N-VIVO CALCIUM SCORE ON IA CHASSIS RELEASE, MODEL RELEASE X.XX

K-Number: K040782 · 2004-07-13

ApplicantImage Analysis, Inc.
Decision Date2004-07-13
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

N-VIVO CALCIUM SCORE ON IA CHASSIS RELEASE, MODEL RELEASE X.XX is the device name listed in this FDA 510(k) record. The listed applicant is Image Analysis, Inc.. It received FDA 510(k) clearance on 2004-07-13 under 510(k) number K040782. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the N-VIVO CALCIUM SCORE ON IA CHASSIS RELEASE, MODEL RELEASE X.XX?

N-VIVO CALCIUM SCORE ON IA CHASSIS RELEASE, MODEL RELEASE X.XX is a medical device that received FDA 510(k) clearance on 2004-07-13. The listed applicant is Image Analysis, Inc.. The 510(k) number is K040782.

When did N-VIVO CALCIUM SCORE ON IA CHASSIS RELEASE, MODEL RELEASE X.XX receive FDA 510(k) clearance?

N-VIVO CALCIUM SCORE ON IA CHASSIS RELEASE, MODEL RELEASE X.XX received FDA 510(k) clearance on 2004-07-13, under 510(k) number K040782.

Who is the listed applicant for N-VIVO CALCIUM SCORE ON IA CHASSIS RELEASE, MODEL RELEASE X.XX?

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

What is the FDA product code for N-VIVO CALCIUM SCORE ON IA CHASSIS RELEASE, MODEL RELEASE X.XX?

The FDA product code for N-VIVO CALCIUM SCORE ON IA CHASSIS RELEASE, MODEL RELEASE X.XX is JAK.

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Related Devices (Code: JAK)

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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