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510(k) K213691

Solas OR by Cirdan Imaging, Ltd. — Product Code MWP

K213691 is an FDA 510(k) premarket notification submitted by Cirdan Imaging, Ltd. for the device "Solas OR". The FDA issued a decision of Substantially Equivalent on December 22, 2021. The device falls under product code MWP (Cabinet, X-Ray System), a Class II device regulated under 21 CFR 892.1680.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 2021
Date Received
November 23, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Cabinet, X-Ray System
Device Class
Class II
Regulation Number
892.1680
Review Panel
RA
Submission Type

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  • K210957 — Kubec Xpert 80 Radiography System (August 31, 2021)
  • K210956 — Kubtec Mozart (XPERT42) (August 31, 2021)
  • K202713 — TrueView 100 Pro (November 18, 2020)
  • K200756 — Kubtec Mozart Supra (June 12, 2020)
  • K192939 — Volumetric Specimen Imager (December 27, 2019)
  • K193317 — CoreLite X-Ray Specimen Cabinet (December 13, 2019)
  • K183624 — Kubtec Mozart (Xpert42) (June 20, 2019)

FDA data resources