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FDA 510(k)

SONOS 5500 IMAGING SYSTEM

K-Number: K971116 · 1998-01-12

ApplicantHewlett-Packard Co.
Decision Date1998-01-12
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SONOS 5500 IMAGING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Hewlett-Packard Co.. It received FDA 510(k) clearance on 1998-01-12 under 510(k) number K971116. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SONOS 5500 IMAGING SYSTEM?

SONOS 5500 IMAGING SYSTEM is a medical device that received FDA 510(k) clearance on 1998-01-12. The listed applicant is Hewlett-Packard Co.. The 510(k) number is K971116.

When did SONOS 5500 IMAGING SYSTEM receive FDA 510(k) clearance?

SONOS 5500 IMAGING SYSTEM received FDA 510(k) clearance on 1998-01-12, under 510(k) number K971116.

Who is the listed applicant for SONOS 5500 IMAGING SYSTEM?

The FDA 510(k) record lists Hewlett-Packard Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SONOS 5500 IMAGING SYSTEM?

The FDA product code for SONOS 5500 IMAGING SYSTEM is ITX.

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Other records listing Hewlett-Packard Co. 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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Related Devices (Code: ITX)

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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