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FDA 510(k)

SIDEXIS DIGITAL RADIOGRAPHY SYSTEM

K-Number: K972168 · 1997-09-05

ApplicantPelton & Crane Co.
Decision Date1997-09-05
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SIDEXIS DIGITAL RADIOGRAPHY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Pelton & Crane Co.. It received FDA 510(k) clearance on 1997-09-05 under 510(k) number K972168. 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 SIDEXIS DIGITAL RADIOGRAPHY SYSTEM?

SIDEXIS DIGITAL RADIOGRAPHY SYSTEM is a medical device that received FDA 510(k) clearance on 1997-09-05. The listed applicant is Pelton & Crane Co.. The 510(k) number is K972168.

When did SIDEXIS DIGITAL RADIOGRAPHY SYSTEM receive FDA 510(k) clearance?

SIDEXIS DIGITAL RADIOGRAPHY SYSTEM received FDA 510(k) clearance on 1997-09-05, under 510(k) number K972168.

Who is the listed applicant for SIDEXIS DIGITAL RADIOGRAPHY SYSTEM?

The FDA 510(k) record lists Pelton & Crane Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SIDEXIS DIGITAL RADIOGRAPHY SYSTEM?

The FDA product code for SIDEXIS DIGITAL RADIOGRAPHY SYSTEM is EHD.

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Other records listing Pelton & Crane 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: EHD)

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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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