Elekta Unity

FDA UDI

Class II (US FDA UDI)

by Elekta Inc.

Identity

Trade Name: Elekta Unity FDA UDI
Generic Name: Linear accelerator system FDA UDI
Device Name: INDEXING BAR FDA UDI
Model / Reference: 1059073 FDA UDI
Description: INDEXING BAR FDA UDI

Identifiers

Primary DI / UDI-DI: 05060191071420 FDA UDI
510(k) Number: K182076 FDA UDI
FDA Product Code: IYE FDA UDI
GMDN Term: Linear accelerator system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.5050 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

MRI Safety

MR Safe FDA UDI

Category: Linear accelerator system

Elekta Unity by Elekta Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Linear accelerator system.

SW, Legal Labelling Install Disk, 5.1.9 — Accuray Incorporated · Class II
Radixact®, Treatment Delivery Console (TDC) — Accuray Incorporated · Class II
Radixact®, Treatment Delivery Console — Accuray Incorporated · Class II
Clinac iX — Varian Medical Systems, Inc · Class II
TomoHDA® Treatment Delivery System — Accuray Incorporated · Class II
LIAC — Sit Sordina Iort Technologies Spa · Class II
reNEW™ Certified Pre-Owned System — Accuray Incorporated · Class II
CyberKnife® M6™ Systems — Accuray Incorporated · Class II

Cleared under the same submission

K182076 also covers:

Elekta Unity — Elekta Inc.
Elekta Unity — Elekta Inc.

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: Elekta Inc.

Sources (1)

FDA UDI 2a757db5-ab8f-42dc-af4a-a0ebab9defa1 35 fields · synced May 30, 2026