Toshiba Scanner

FDA UDI

Class II (US FDA UDI)

by Canon Medical Systems Corporation

Identity

Trade Name: TOSHIBA SCANNER FDA UDI
Generic Name: PET/CT system FDA UDI
Device Name: This device was previously sold by TOSHIBA MEDICAL SYSTEMS CORPORATION under the brand name TOSHIBA SCANNER. Effective Jan 2018, the company name changed to CANON MEDICAL SYSTEMS CORPORATION. The device brand name is now CT SCANNER . FDA UDI
Model / Reference: PCA-9000A FDA UDI
Description: This device was previously sold by TOSHIBA MEDICAL SYSTEMS CORPORATION under the brand name TOSHIBA SCANNER. Effective Jan 2018, the company name changed to CANON MEDICAL SYSTEMS CORPORATION. The device brand name is now CT SCANNER . FDA UDI

Identifiers

Primary DI / UDI-DI: 04987670100543 FDA UDI
510(k) Number: K140651 FDA UDI
FDA Product Code: KPS FDA UDI
GMDN Term: PET/CT system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 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

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Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

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Manufacturing Date

FDA UDI

Category: PET/CT system

Toshiba 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 1783beb5-af0b-40b3-ba2c-f37ff8f3e3ff 35 fields · synced Jun 8, 2026