BoneView

FDA UDIEUDAMED

Class II (US FDA UDI)

by Gleamer Sas

Identity

Trade Name: BoneView FDA UDI
Generic Name: Radiological PACS software FDA UDI
Model / Reference: 1.X-US FDA UDI

Identifiers

Primary DI / UDI-DI: 03770020839009 FDA UDI
510(k) Number: K212365 FDA UDI
FDA Product Code: QBS FDA UDI
GMDN Term: Radiological PACS software FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.2090 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

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Radiological PACS software

BoneView by Gleamer Sas — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Radiological PACS software.

AVIEW — CORELINE SOFT CO., LTD. · Class II
ThinkingNet — THINKING SYSTEMS CORP. · Class II
IMAGEGRID RADIOLOGY VIEWER SYSTEM — Candelis, Inc. · Class II
EAGLESOFT — PATTERSON TECHNOLOGY CENTER · Class II
QuantX — Qlarity Imaging · Class II
interWORKS — Avreo, Inc. · Class I
NovaPACS — Novarad Corporation · Class II
OrthoNext™ Platform System Software — Orthofix, Inc. · Class II

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class II	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Gleamer Sas

Sources (2)

FDA UDI 75ae1987-ddb7-4a3a-8543-a60921c49616 33 fields · synced Jun 18, 2026
EUDAMED 1 fields · synced Jun 2, 2026