Pet-Ct Scanner

FDA UDI

Class II (US FDA UDI)

by Canon Medical Systems Corporation

Identity

Trade Name: PET-CT SCANNER FDA UDI
Generic Name: PET/CT system FDA UDI
Device Name: This device is used to acquire transaxial images of any desired region of the body, providing a wide range of diagnostic capabilities. FDA UDI
Model / Reference: PCD-1000A FDA UDI
Description: This device is used to acquire transaxial images of any desired region of the body, providing a wide range of diagnostic capabilities. FDA UDI

Identifiers

Primary DI / UDI-DI: 04987670103810 FDA UDI
510(k) Number: K203314 FDA UDI
FDA Product Code: JAK FDA UDI
KPS FDA UDI
GMDN Term: PET/CT system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.1750 FDA UDI
892.1200 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: PET/CT system

Pet-Ct Scanner by Canon Medical Systems Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Canon Medical Systems Corporation

Sources (1)

FDA UDI a4c6fff4-8314-4016-90d1-105b489a7cc3 34 fields · synced May 30, 2026