Alta

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref RT-4800-H30Model Couchtops, Overlays, and Multipurpose Devices

by Qfix

Identity

Trade Name: Alta FDA UDI
Generic Name: Patient positioner base plate FDA UDI
Device Name: Alta Opti-Handles, 30cm (set of 2) FDA UDI
Model / Reference: RT-4800-H30 EUDAMEDFDA UDI
Couchtops, Overlays, and Multipurpose Devices EUDAMED
Description: Alta Opti-Handles, 30cm (set of 2) FDA UDI

Identifiers

Catalog Number: RT-4800-H30 FDA UDI
Primary DI / UDI-DI: 00841962119733 EUDAMEDFDA UDI
Basic UDI-DI: 8419621COUCHTOPSMPD6F EUDAMED
510(k) Number: K193243 FDA UDI
FDA Product Code: FRZ FDA UDI
IYE FDA UDI
JAI FDA UDI
JAK FDA UDI
KPS FDA UDI
LHN FDA UDI
LNH FDA UDI
OUO FDA UDI
EMDN Code: Z12011299 PATIENT POSITIONING INSTRUMENTS – OTHER EUDAMED
GMDN Term: Patient positioner base plate FDA UDI

Classification

Device Class: Class I EUDAMED
Class II FDA UDI
Regulation Number: 880.6775 FDA UDI
892.5050 FDA UDI
892.5770 FDA UDI
892.1750 FDA UDI
892.1200 FDA UDI
892.1000 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: Patient positioner base plate

Alta by Qfix — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Patient positioner base plate.

Meicen — Guangdong Meicen Medical Equipment Co., Ltd. · Class I
Type-S™ Variable Axis Baseplate — Medtec LLC · Class II
Posifix® -2 Baseplate — Medtec LLC · Class II
MR Posi-S™ Adapter — Medtec LLC · Class II
Uni-frame® Baseplate — Medtec LLC · Class II
Prone Head Holder — Medtec LLC · Class I
Arthrex TRIMANO quick adapter — Maquet, Inc. · Class I
Uni-frame® Baseplate — Medtec LLC · Class II

Cleared under the same submission

K193243 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: Qfix

Sources (2)

FDA UDI 041e669c-7a2a-4c02-a862-f48f3ea559a0 36 fields · synced Jul 10, 2026
EUDAMED e2754ff7-08c3-4f75-9e01-2906ff57abb0 61 fields · synced Jul 10, 2026