FDA 510(k)

HAMAMATSU PET SCANNER, MODEL SHR-22000

K-Number: K982171 · 1998-09-17

Decision Date1998-09-17

Product CodeKPS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

HAMAMATSU PET SCANNER, MODEL SHR-22000 is the device name listed in this FDA 510(k) record. The listed applicant is Hamamatsu Photonics K.K.. It received FDA 510(k) clearance on 1998-09-17 under 510(k) number K982171. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HAMAMATSU PET SCANNER, MODEL SHR-22000?

HAMAMATSU PET SCANNER, MODEL SHR-22000 is a medical device that received FDA 510(k) clearance on 1998-09-17. The listed applicant is Hamamatsu Photonics K.K.. The 510(k) number is K982171.

When did HAMAMATSU PET SCANNER, MODEL SHR-22000 receive FDA 510(k) clearance?

HAMAMATSU PET SCANNER, MODEL SHR-22000 received FDA 510(k) clearance on 1998-09-17, under 510(k) number K982171.

Who is the listed applicant for HAMAMATSU PET SCANNER, MODEL SHR-22000?

The FDA 510(k) record lists Hamamatsu Photonics K.K. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HAMAMATSU PET SCANNER, MODEL SHR-22000?

The FDA product code for HAMAMATSU PET SCANNER, MODEL SHR-22000 is KPS.

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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.