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FDA 510(k)

FS IV MINI C-ARM SYSTEM

K-Number: K974058 · 1998-01-12

ApplicantHologic, Inc.
Decision Date1998-01-12
Product CodeJAA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

FS IV MINI C-ARM SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Hologic, Inc.. It received FDA 510(k) clearance on 1998-01-12 under 510(k) number K974058. The device is classified under product code JAA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FS IV MINI C-ARM SYSTEM?

FS IV MINI C-ARM SYSTEM is a medical device that received FDA 510(k) clearance on 1998-01-12. The listed applicant is Hologic, Inc.. The 510(k) number is K974058.

When did FS IV MINI C-ARM SYSTEM receive FDA 510(k) clearance?

FS IV MINI C-ARM SYSTEM received FDA 510(k) clearance on 1998-01-12, under 510(k) number K974058.

Who is the listed applicant for FS IV MINI C-ARM SYSTEM?

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

What is the FDA product code for FS IV MINI C-ARM SYSTEM?

The FDA product code for FS IV MINI C-ARM SYSTEM is JAA.

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Related Devices (Code: JAA)

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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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