DEVICE: CardioMD (05711665002012)

Device Identifier (DI) Information

CardioMD
CorCam Gamma Camera System
In Commercial Distribution
9PMS3060
Ddd-Diagnostic A/S
05711665002012
GS1

1
305116642 *Terms of Use
Gamma Camera System
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Stationary gamma camera system An assembly of static diagnostic devices designed to record, quantify, and analyse radionuclide emissions (primarily gamma rays) produced during the decay of radiopharmaceuticals or other radiation emitting materials injected into, or ingested by, a patient. It consists of an analogue or digital detector based nuclear medicine (NM) planar imaging system, crystal(s), a collimator and a set of photomultiplier tubes or photo diodes. Gamma rays pass through holes in the collimator causing light flashes within the crystal corresponding to the sites of origin in the body and the amplitude of the flash is calculated by a computer to create images.
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FDA Product Code

[?]
Product Code Product Code Name
KPS System, Tomography, Computed, Emission
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K011611 000
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Width: 284 Centimeter
Depth: 150 Centimeter
Height: 150 Centimeter
Weight: 815 Kilogram
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Device Record Status

4b283b3a-ca80-481f-8fe8-11c043f0fd04
August 06, 2018
1
July 04, 2018
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
9999999999
support@ddd-diagnostic.dk
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