Question 1

What types of medical devices does Pausch, L.L.C. manufacture?

Accepted Answer

Pausch, L.L.C. specializes in diagnostic X-ray equipment accessories and components. Their product line includes floor-standing and ceiling-mounted tube supports for X-ray systems, non-powered diagnostic X-ray system tables, positioning frames for patient alignment, and X-ray film cassette holders. These devices are designed to support radiographic imaging workflows in clinical settings.

Question 2

Where is Pausch, L.L.C. based, and what is its primary market focus?

Accepted Answer

Pausch, L.L.C. is based in the United States. Their focus is on supplying diagnostic X-ray equipment accessories and components tailored for radiographic imaging systems, ensuring compatibility with existing X-ray systems in medical facilities across the country.

Question 3

Which regulatory registries list Pausch, L.L.C.’s devices?

Accepted Answer

Pausch, L.L.C.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency of their products, which are intended for use in diagnostic imaging within the U.S.

Question 4

How are Pausch, L.L.C.’s devices classified under FDA regulations?

Accepted Answer

Pausch, L.L.C.’s devices fall under FDA’s Class I and Class II classifications. Class I generally includes low-risk devices requiring general controls, while Class II involves special controls to ensure safety and effectiveness. The classification depends on the specific device’s design and intended use, such as tube supports or positioning frames.

Question 5

What is the intended use of Pausch, L.L.C.’s X-ray equipment accessories?

Accepted Answer

Pausch, L.L.C.’s X-ray equipment accessories are designed to enhance diagnostic imaging workflows by providing stable support for X-ray tubes (floor-standing or ceiling-mounted), secure patient positioning, and proper film cassette handling. These components are meant to integrate seamlessly with existing radiographic systems to improve imaging quality and efficiency in clinical environments.

Device	Model / Reference	Registries	Class	Status
Paxis 100	RH	FDA UDI	Class I	Active
Cirrus	R	FDA UDI	Class I	Active
Paxis 100 Auto	LH	FDA UDI	Class I	Active
Patient Table	Regular	FDA UDI	Class II	Active
Patient Table	Regular	FDA UDI	Class II	Active
Cirrus	L	FDA UDI	Class I	Active
CombiMax	Right Hand	FDA UDI	Class II	Active
FS 100 Wallstand	Right Hand	FDA UDI	Class I	Active
Paxis 100	LH	FDA UDI	Class I	Active
ElevatorMax	Base	FDA UDI	Class II	Active
Vms 400	Base	FDA UDI	Class I	Active
Paxis 100 Auto	RH	FDA UDI	Class I	Active
Patient Table	Regular	FDA UDI	Class II	Active
FS 100 Wallstand	Left Hand	FDA UDI	Class I	Active
Paxis 100 Auto	RH	FDA UDI	Class I	Active
Paxis 200	Base	FDA UDI	Class I	Active
CombiMax	Left Hand	FDA UDI	Class II	Active

Pausch, L.L.C.

What Pausch, L.L.C. makes

Frequently asked questions

Information

Catalogue (17)

Related Companies

Authorised Representatives

Importers

Notified Bodies

Authorities