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510(k) K230136

TrueView 200 Pro-US Specimen Radiography System (TrueView 200 Pro-US) by Compai Healthcare (Suzhou) Co.,Ltd — Product Code MWP

K230136 is an FDA 510(k) premarket notification submitted by Compai Healthcare (Suzhou) Co.,Ltd for the device "TrueView 200 Pro-US Specimen Radiography System (TrueView 200 Pro-US)". The FDA issued a decision of Substantially Equivalent on April 24, 2023. The device falls under product code MWP (Cabinet, X-Ray System), a Class II device regulated under 21 CFR 892.1680. Compai Healthcare (Suzhou) Co.,Ltd has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 24, 2023
Date Received
January 18, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Compai Healthcare (Suzhou) Co.,Ltd

  • K230140 — TrueView Core 100Pro-US Core Specimen Radiography System (TrueView Core 100Pro-U (April 24, 2023)

Other clearances for product code MWP

  • K230140 — TrueView Core 100Pro-US Core Specimen Radiography System (TrueView Core 100Pro-U (April 24, 2023)
  • K213691 — Solas OR (December 22, 2021)
  • K210955 — Kubtec Mozart Supra (XPERT 84) Radiography System (September 20, 2021)
  • K210956 — Kubtec Mozart (XPERT42) (August 31, 2021)
  • K210957 — Kubec Xpert 80 Radiography System (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