9PMS3060-A02

Organization name

DDD-Diagnostic A/S

SRN

DK-MF-000009162

Manufacturer status

Active

7 warnings recorded — scroll inside the panel to see all entries.

• CW999

  WARNING: Do not use the CardioMD IV system for any application until you are sure that the Image Performance Quality Assurance has been satisfactorily completed, and that the general maintenance program is up to date. If any part of the equipment or system is known (or suspected) to be operating improperly or wrongly-adjusted, DO NOT USE the system until a repair has been made.
• CW999

  WARNING: Do not operate the CardioMD IV system until you have read, understood and know all the safety information, safety procedures and emergency procedures contained in this Safety section. Operation of the CardioMD IV system without a proper awareness of how to use it safely could lead to fatal or other serious personal injury.
• CW999

  WARNING: Do not operate the CardioMD IV system until you have received adequate and proper training in its safe and effective operation. If you are unsure of your ability to operate this equipment safely and effectively DO NOT USE IT. Operation of this equipment without proper and adequate training could lead to fatal or other serious personal injury. It could also lead to clinical misdiagnosis.
• CW999

  WARNING: Never attempt to remove, modify, override or forcibly move any safety device on the equipment. Interfering with safety devices could lead to fatal or other serious personal injury.
• CW999

  WARNING: Do not use the CardioMD IV system for any purpose other than those for which it is intended. Operation of the CardioMD IV system for unintended purposes, or with incompatible equipment, could lead to fatal or other serious injury. It could also lead to clinical misdiagnosis.
• CW999

  Contra-indication: Do not use the system for patients who are restricted from having a nuclear medicine procedure (according to either the referring physician or the radiologist).
• CW999

  Contra-indication: Also, operators should follow the guidelines and contraindications contained in the radiopharmaceutical package insert.

Primary placement in Denmark; available across 1 country total.

Trade name

not provided

UDI-DI code

05711665002012

Basic UDI-DI

B-05711665002012

Reference / catalog number

9PMS3060-A02

Issuing entity

GS1

Risk category

Class IIa

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

CardioMD IV is a dedicated gamma camera system for functional imaging of the heart.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• Z11020104FIXED STATION GAMMA CAMERAS WITH MULTIPLE HEADS - WITHOUT ‘TOTAL BODY’ ACQUISITION