- Organization name
- UDI-DI code
- Reference / catalog number
EUDAMED last updated this device on Oct 20, 2021
8631520003CBCTDevicesCLInReach is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIb. Manufactured by CurveBeam LLC. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
008631520003311020US-MF-00000403328620146078-02(01)00863152000331
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
3 warnings recorded — scroll inside the panel to see all entries.
Maintain distance from exposed radiation source in accordance with the facility survey or site plan and shielding designs, provided by a medical physicist.Maintain distance from exposed radiation source in accordance with the facility survey or site plan and shielding designs, provided by a medical physicist. Ensure that flexable shields, provided with the machine, are both attached, in place and used during the duration of the scan.
Installation and system wiring must meet all requirements of local governing authorities. Please check your local authorities and local codes to determine best practices for a safe installation. Do not place any liquid or food on any part of the consoles or other modules of the system. Observe all fire regulations. Fire extinguishers should be provided for both electrical and nonelectrical fires. All operators should be fully trained in the use of fire extinguishers and other firefighting equipment and in local fire procedures. In the event of an electrical fire, only use extinguishers that are labelled for that purpose. Using water or other liquids on an electrical fire can lead to fatal or other serious personal injury. In the event of an electrical fire, to reduce the risk of electrical shock, try to isolate the equipment from the electric source before attempting to extinguish the fire. To avoid risk of electric shock, this equipment must only be connected to a supply main with protective earth.
Please refer to instruction manual before operating the equipment, which includes all cautions, warnings and safety measures.
Sterile
A sterile device is supplied free of viable micro-organisms — flagged so that it is handled, stored and used to preserve that sterile state.
Single-use device
A single-use device is intended to be used on one patient during a single procedure and then discarded — not reprocessed or reused.
Contains latex
A "contains latex" flag warns that a device contains natural rubber latex, which can trigger allergic reactions in sensitive patients.
CMR substance
A CMR flag warns that a device contains a substance that is carcinogenic, mutagenic or toxic to reproduction above a defined threshold.
Endocrine-disrupting substance
An endocrine-disruptor flag warns that a device contains a substance with endocrine-disrupting properties above a defined threshold.
Primary placement in Germany; available across 10 countries total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | — | Still on market |
| Belgium | — | Still on market |
| Denmark | — | Still on market |
| Spain | — | Still on market |
| France | — | Still on market |
| Hungary | — | Still on market |
| Italy | — | Still on market |
| Norway | — | Still on market |
| Poland | — | Still on market |
| Romania | — | Still on market |
European Medical Device Nomenclature — the EU product classification assigned to this device.
Z11030699COMPUTED TOMOGRAPHS (CT) - OTHERPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
View in glossary →UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
View in glossary →MDR risk classes
MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.
View in glossary →Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →Certificate health across this manufacturer's portfolio.
28620146078-02IssuedNotified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
View in glossary →