FDA 510(k)

MODEL 3000 NUCLEAR CAMERA

K-Number: K882312 · 1988-07-14

Decision Date1988-07-14

Product CodeIYX

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

MODEL 3000 NUCLEAR CAMERA is the device name listed in this FDA 510(k) record. The listed applicant is Ohio Imaging, Inc.. It received FDA 510(k) clearance on 1988-07-14 under 510(k) number K882312. The device is classified under product code IYX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL 3000 NUCLEAR CAMERA?

MODEL 3000 NUCLEAR CAMERA is a medical device that received FDA 510(k) clearance on 1988-07-14. The listed applicant is Ohio Imaging, Inc.. The 510(k) number is K882312.

When did MODEL 3000 NUCLEAR CAMERA receive FDA 510(k) clearance?

MODEL 3000 NUCLEAR CAMERA received FDA 510(k) clearance on 1988-07-14, under 510(k) number K882312.

Who is the listed applicant for MODEL 3000 NUCLEAR CAMERA?

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

What is the FDA product code for MODEL 3000 NUCLEAR CAMERA?

The FDA product code for MODEL 3000 NUCLEAR CAMERA is IYX.

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Other records listing Ohio Imaging, Inc. as applicant

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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.