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FDA 510(k)

PXI (PERSONAL X-RAY IMAGER) 512

K-Number: K881993 · 1988-09-19

ApplicantOklahoma Digital Technologies, Inc.
Decision Date1988-09-19
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PXI (PERSONAL X-RAY IMAGER) 512 is the device name listed in this FDA 510(k) record. The listed applicant is Oklahoma Digital Technologies, Inc.. It received FDA 510(k) clearance on 1988-09-19 under 510(k) number K881993. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PXI (PERSONAL X-RAY IMAGER) 512?

PXI (PERSONAL X-RAY IMAGER) 512 is a medical device that received FDA 510(k) clearance on 1988-09-19. The listed applicant is Oklahoma Digital Technologies, Inc.. The 510(k) number is K881993.

When did PXI (PERSONAL X-RAY IMAGER) 512 receive FDA 510(k) clearance?

PXI (PERSONAL X-RAY IMAGER) 512 received FDA 510(k) clearance on 1988-09-19, under 510(k) number K881993.

Who is the listed applicant for PXI (PERSONAL X-RAY IMAGER) 512?

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

What is the FDA product code for PXI (PERSONAL X-RAY IMAGER) 512?

The FDA product code for PXI (PERSONAL X-RAY IMAGER) 512 is LLZ.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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