D630 Upgrade

FDA UDI

Class II (US FDA UDI)

by GE Hualun Medical Systems Co., Ltd

Identity

Trade Name: D630 Upgrade FDA UDI
Generic Name: Stationary gamma camera system FDA UDI
Device Name: B615 to D630 upgrade kits option with new ROTOR FDA UDI
Model / Reference: H2401XF FDA UDI
Description: B615 to D630 upgrade kits option with new ROTOR FDA UDI

Identifiers

Catalog Number: H2401XF FDA UDI
Primary DI / UDI-DI: 00840682145503 FDA UDI
510(k) Number: K111445 FDA UDI
FDA Product Code: KPS FDA UDI
GMDN Term: Stationary gamma camera 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

Yes

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

Yes

FDA UDI

Category: Stationary gamma camera system

D630 Upgrade by GE Hualun Medical Systems Co., Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K111445 also covers:

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: GE Hualun Medical Systems Co., Ltd

Sources (1)

FDA UDI 3da7a092-90c2-4ed5-8d51-622af2e040c2 35 fields · synced May 30, 2026