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IPPS Overlay

FDA UDI

Class II (US FDA UDI)

by Medtec LLC

Identity

Trade Name
IPPS Overlay FDA UDI
Generic Name
Indexed-immobilization patient positioning system FDA UDI
Device Name
Reusable non-sterile Siemens Biograph PET/CT cradle top FDA UDI
Model / Reference
MTIL6062 FDA UDI
Description
Reusable non-sterile Siemens Biograph PET/CT cradle top FDA UDI

Identifiers

Catalog Number
MTIL6062 FDA UDI
Primary DI / UDI-DI
00841439105559 FDA UDI
510(k) Number
K973842 FDA UDI
FDA Product Code
IXQ FDA UDI
GMDN Term
Indexed-immobilization patient positioning system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1980 FDA UDI
Commercial Distribution
Not 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

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Width — 22.6 Inch FDA UDI
Length — 87.4 Inch FDA UDI

The IPPS Overlay is a reusable, non-sterile Siemens Biograph PET/CT cradle top designed for radiation therapy applications. It provides an indexed treatment or imaging table that ensures both adequate positioning and immobilization of patients and helps ensure reproducible alignment between target portions of the patient's anatomy and radiation beams.

Cleared under the same submission

K973842 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medtec LLC

Sources (1)

  • FDA UDI 9f3823b7-8e72-4e3e-b4c4-c16c816f782c 38 fields · synced Jul 26, 2026