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FDA 510(k)

PANATOME

K-Number: K991518 · 1999-06-18

ApplicantImaging Sciences Intl., Inc.
Decision Date1999-06-18
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PANATOME is the device name listed in this FDA 510(k) record. The listed applicant is Imaging Sciences Intl., Inc.. It received FDA 510(k) clearance on 1999-06-18 under 510(k) number K991518. The device is classified under product code EHD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PANATOME?

PANATOME is a medical device that received FDA 510(k) clearance on 1999-06-18. The listed applicant is Imaging Sciences Intl., Inc.. The 510(k) number is K991518.

When did PANATOME receive FDA 510(k) clearance?

PANATOME received FDA 510(k) clearance on 1999-06-18, under 510(k) number K991518.

Who is the listed applicant for PANATOME?

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

What is the FDA product code for PANATOME?

The FDA product code for PANATOME is EHD.

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Other records listing Imaging Sciences Intl., Inc. as applicant

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Related Devices (Code: EHD)

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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