FDA.reportPublic FDA data

Solas OR

Primary DI
05060508820062
Brand
Solas OR
Company
CIRDAN IMAGING LIMITED
Model
1
Device description
X-ray Specimen Imaging Cabinet
Published
2026-05-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
MWPCabinet, X-Ray System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MWPCabinet, X-Ray SystemRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K213691000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213691000Solas ORCirdan Imaging, Ltd.2021-12-22MWP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060508820062PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060508820062050605088200625060508820062

GMDN Terms#

Term, Definition table
TermDefinition
Tissue specimen x-ray system IVDAn assembly of devices designed to produce an x-ray image of a tissue sample (e.g., stereotactic biopsy cores taken during mammographic procedures) and/or an amputated body part, by generating and controlling x-ray beams and recording the absorption patterns of the x-rays. The system typically includes a cabinet where the specimen is placed and a screen; the image is generated via digital imaging methods.

Contacts#

Phone, Email table
PhoneEmail
+442892660880info@cirdan.com

Regulatory Flags#

DUNS number
216744109
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060508820024ULTRA Laboratory Information System4.7, 4.8, 4.92019-10-08
05060508820031ULTRA Transfusion Medicine4.7, 4.8, 4.92019-10-08
05060508820017CoreLite12020-03-31
05060508820000Pathnet Blood Bank Transfusion (L-2300)4.12016-11-21

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25420045516622FAXITRON COREHologic, Inc.MWP2023-04-11
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15420045516625FAXITRON COREHologic, Inc.MWP2023-04-11
15420045516649FAXITRON MAMMOTOMEHologic, Inc.MWP2023-04-11
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15420045514928Faxitron Path+Hologic, Inc.MWP2021-08-17
15420045515031FAXITRON PATHHologic, Inc.MWP2021-07-30
15420045514218FAXITRON COREHologic, Inc.MWP2021-07-15
06973166110026TrueViewCompAI Healthcare (Shenzhen) Co.,ltdMWP2021-01-22
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