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FDA 510(k)

WINSCAN AUTOMATED IMAGING SYSTEM

K-Number: K980375 · 1998-06-09

ApplicantApplied Imaging Corp.
Decision Date1998-06-09
Product CodeJOY
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

WINSCAN AUTOMATED IMAGING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Applied Imaging Corp.. It received FDA 510(k) clearance on 1998-06-09 under 510(k) number K980375. The device is classified under product code JOY. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WINSCAN AUTOMATED IMAGING SYSTEM?

WINSCAN AUTOMATED IMAGING SYSTEM is a medical device that received FDA 510(k) clearance on 1998-06-09. The listed applicant is Applied Imaging Corp.. The 510(k) number is K980375.

When did WINSCAN AUTOMATED IMAGING SYSTEM receive FDA 510(k) clearance?

WINSCAN AUTOMATED IMAGING SYSTEM received FDA 510(k) clearance on 1998-06-09, under 510(k) number K980375.

Who is the listed applicant for WINSCAN AUTOMATED IMAGING SYSTEM?

The FDA 510(k) record lists Applied Imaging Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WINSCAN AUTOMATED IMAGING SYSTEM?

The FDA product code for WINSCAN AUTOMATED IMAGING SYSTEM is JOY.

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Other records listing Applied Imaging Corp. 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: JOY)

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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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