Brivo 615

FDA UDI

Class II (US FDA UDI)

by GE Hualun Medical Systems Co., Ltd

Identity

Trade Name: Brivo 615 FDA UDI
Generic Name: Stationary gamma camera system FDA UDI
Device Name: TANDEM GANTRY-B615 Medical Device FDA UDI
Model / Reference: 5376496-15 FDA UDI
Description: TANDEM GANTRY-B615 Medical Device FDA UDI

Identifiers

Primary DI / UDI-DI: 00840682117869 FDA UDI
510(k) Number: K113350 FDA UDI
FDA Product Code: JAK FDA UDI
KPS FDA UDI
GMDN Term: Stationary gamma camera 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

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

Brivo 615 by GE Hualun Medical Systems Co., Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Stationary gamma camera system.

850ES to 850 Upgrade — Ge Medical Systems Israel , Ltd. · Class II
870ES to 870 DR Upgrade — Ge Medical Systems Israel , Ltd. · Class II
Discovery — Ge Medical Systems Israel , Ltd. · Class II
NMCT — Ge Medical Systems Israel , Ltd. · Class II
Discovery — Ge Medical Systems Israel , Ltd. · Class II
870DR to 870 CZT Upgrade — Ge Medical Systems Israel , Ltd. · Class II
NMCT — Ge Medical Systems Israel , Ltd. · Class II
BodyMD — Ddd-Diagnostic A/S · Class II

Cleared under the same submission

K113350 also covers:

Brivo — GE Hualun Medical Systems Co., Ltd

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: GE Hualun Medical Systems Co., Ltd

Sources (1)

FDA UDI 413648be-c496-4b4d-9f78-226678b9f0a6 34 fields · synced Jun 8, 2026