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FDA 510(k)

PRISM 3000XPV SYSTEM (210714)

K-Number: K961577 · 1996-07-23

ApplicantPhilips Medical Systems (Cleveland), Inc.
Decision Date1996-07-23
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PRISM 3000XPV SYSTEM (210714) is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems (Cleveland), Inc.. It received FDA 510(k) clearance on 1996-07-23 under 510(k) number K961577. 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 PRISM 3000XPV SYSTEM (210714)?

PRISM 3000XPV SYSTEM (210714) is a medical device that received FDA 510(k) clearance on 1996-07-23. The listed applicant is Philips Medical Systems (Cleveland), Inc.. The 510(k) number is K961577.

When did PRISM 3000XPV SYSTEM (210714) receive FDA 510(k) clearance?

PRISM 3000XPV SYSTEM (210714) received FDA 510(k) clearance on 1996-07-23, under 510(k) number K961577.

Who is the listed applicant for PRISM 3000XPV SYSTEM (210714)?

The FDA 510(k) record lists Philips Medical Systems (Cleveland), Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PRISM 3000XPV SYSTEM (210714)?

The FDA product code for PRISM 3000XPV SYSTEM (210714) is KPS.

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Related Devices (Code: KPS)

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.

K261305MICSI-PETMicrostructure Imaging, Inc.K261427uMI Panvivo (uMI Panvivo M)Shanghai United Imaging Healthcare Co., Ltd.K261315Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (11364752);Symbia Pro.specta X7 (11364753);Symbia Pro.specta VA40 FamilySiemens Medical Solutions USA, Inc.K260524uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES)Shanghai United Imaging Healthcare Co., Ltd.K253564uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES)Shanghai United Imaging Healthcare Co., Ltd.K254001VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464)Spectrum Dynamics Medical, Ltd.

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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