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Alta

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref RT-4800-02Model Couchtops, Overlays, and Multipurpose Devices

by Qfix

Identity

Trade Name
Alta FDA UDI
Generic Name
Indexed-immobilization patient positioning system FDA UDI
Device Name
Alta ArmShuttle Elite FDA UDI
Model / Reference
RT-4800-02 EUDAMEDFDA UDI
Couchtops, Overlays, and Multipurpose Devices EUDAMED
Description
Alta ArmShuttle Elite FDA UDI

Identifiers

Catalog Number
RT-4800-02 FDA UDI
Primary DI / UDI-DI
00841962119603 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
Indexed-immobilization patient positioning system 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

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

Yes

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

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

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Indexed-immobilization patient positioning system

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

Similar devices

Also classified as Indexed-immobilization patient positioning system.

Cleared under the same submission

K193243 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Qfix

Sources (2)

  • FDA UDI 8654adbf-22fe-431c-9e1c-ef6c8899c514 36 fields · synced Jul 15, 2026
  • EUDAMED e22862ce-387f-4b90-a77a-cc62446b9b12 61 fields · synced Jul 15, 2026