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FDA 510(k)

PHOTON RADIOSURGERY SYSTEM PRS400

K-Number: K980526 · 1998-07-27

ApplicantPec Photoelectron Corp.
Decision Date1998-07-27
Product CodeJAD
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PHOTON RADIOSURGERY SYSTEM PRS400 is the device name listed in this FDA 510(k) record. The listed applicant is Pec Photoelectron Corp.. It received FDA 510(k) clearance on 1998-07-27 under 510(k) number K980526. The device is classified under product code JAD. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHOTON RADIOSURGERY SYSTEM PRS400?

PHOTON RADIOSURGERY SYSTEM PRS400 is a medical device that received FDA 510(k) clearance on 1998-07-27. The listed applicant is Pec Photoelectron Corp.. The 510(k) number is K980526.

When did PHOTON RADIOSURGERY SYSTEM PRS400 receive FDA 510(k) clearance?

PHOTON RADIOSURGERY SYSTEM PRS400 received FDA 510(k) clearance on 1998-07-27, under 510(k) number K980526.

Who is the listed applicant for PHOTON RADIOSURGERY SYSTEM PRS400?

The FDA 510(k) record lists Pec Photoelectron Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PHOTON RADIOSURGERY SYSTEM PRS400?

The FDA product code for PHOTON RADIOSURGERY SYSTEM PRS400 is JAD.

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Related Devices (Code: JAD)

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

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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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