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iDMS Data Management System

FDA UDI

Class II (US FDA UDI)

by Accuray Incorporated

Identity

Trade Name
iDMS Data Management System FDA UDI
Generic Name
Patient health record information system application software FDA UDI
Device Name
IDMS Data Management System (Version 3.0) FDA UDI
Model / Reference
1061514 FDA UDI
Description
IDMS Data Management System (Version 3.0) FDA UDI

Identifiers

Catalog Number
NA FDA UDI
Primary DI / UDI-DI
00811376030085 FDA UDI
510(k) Number
K161144 FDA UDI
FDA Product Code
MUJ FDA UDI
IYE FDA UDI
GMDN Term
Patient health record information system application software 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Patient health record information system application software

iDMS Data Management System by Accuray Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Patient health record information system application software.

Cleared under the same submission

K161144 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Accuray Incorporated

Sources (1)

  • FDA UDI 38ee4274-b684-4cc2-ba28-ba3c6661a69f 36 fields · synced Jun 9, 2026