Headrest - Timo size F with base

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref MTTIMO2FLModel Head, Neck, and Shoulder Devices

by Medtec LLC

Identity

Trade Name: Headrest - Timo size F with base FDA UDI
Generic Name: Radiological headrest FDA UDI
Device Name: (23.4 x 12.2 x 9.1cm) FDA UDI
Model / Reference: MTTIMO2FL EUDAMEDFDA UDI
Head, Neck, and Shoulder Devices EUDAMED
Description: (23.4 x 12.2 x 9.1cm) FDA UDI

Identifiers

Catalog Number: MTTIMO2FL FDA UDI
Primary DI / UDI-DI: 00841439114964 EUDAMEDFDA UDI
Basic UDI-DI: 8414391OC0005R01AQ EUDAMED
510(k) Number: K080072 FDA UDI
K093738 FDA UDI
FDA Product Code: LNH FDA UDI
IYE FDA UDI
EMDN Code: Z12011299 PATIENT POSITIONING INSTRUMENTS – OTHER EUDAMED
GMDN Term: Radiological headrest FDA UDI

Classification

Device Class: Class I EUDAMED
Class II FDA UDI
Regulation Number: 892.1000 FDA UDI
892.5050 FDA UDI
Market of Registration: Netherlands EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

Yes

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Radiological headrest

Headrest - Timo size F with base by Medtec LLC — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Radiological headrest.

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Nurofit Premiere™ — Qfix · Class I
Neuro Head Holder — Qfix · Class I
SCANCOAT — DOMICO MED-DEVICE, LLC · Class I
SCANCOAT — DOMICO MED-DEVICE, LLC · Class II
DSA-3Q Head Holder — Qfix · Class I
DSA-2T Head Holder — Qfix · Class I
pearltec — Pearl Technology AG · Class I

Cleared under the same submission

K080072 also covers:

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: Medtec LLC

Sources (2)

FDA UDI 8c26d124-716a-413d-babd-c530953903de 36 fields · synced Jun 19, 2026
EUDAMED ea754645-6516-4134-8a3c-28fe84a96ab2 61 fields · synced Jun 19, 2026