9SOL2225-B03

Organization name

DDD-Diagnostic A/S

SRN

DK-MF-000009162

Manufacturer status

Active

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

• CW999

  Warning: Solo is a medical device intended for use by trained and qualified personnel only. Using controls or adjustments or performing procedures other than those specified in this manual may result in severe personal injury or equipment damage.
• CW999

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

  Contra-indication: Prior to initiating any medicine procedure, the physician or technologist must ask women who might be pregnant and who are breast-feeding a child in order to plan for proper medical care for both the mother and the baby.
• CW999

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

Primary placement in Denmark; available across 4 countries total.

Trade name

not provided

UDI-DI code

05711665022256

Basic UDI-DI

B-05711665022256

Reference / catalog number

9SOL2225-B03

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

Solo is a dedicated single-detector gamma camera for planar imaging.

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.

• Z11020102FIXED STATION GAMMA CAMERAS WITH SINGLE HEAD - WITHOUT ‘TOTAL BODY' ACQUISITION