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510(k) K242731

MasteRad MiniX Mobile Digital Imaging System (Mini-X) by Medicatech USA, Inc. — Product Code OWB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 16, 2025
Date Received
September 10, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Interventional Fluoroscopic X-Ray System
Device Class
Class II
Regulation Number
892.1650
Review Panel
RA
Submission Type

Interventional fluoroscopy

Other clearances by Medicatech USA, Inc.

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  • K130377 — KRYSTALRAD NEW SERIESDIGITAL RADIOGRAPHIC PORTABLE RETROFIT SYSTEM (May 17, 2013)
  • K112132 — KRYSTALRAD 660 DIGITAL RADIOGRAPHIC PORTABLE RETROFIT SYSTEM (November 18, 2011)
  • K102284 — KRYSTALRAD 560 (FLAATZ 560) (January 3, 2011)
  • K102285 — KRYSTALRAD (ATAL8) (January 3, 2011)
  • K082798 — DIGITAL DIAGNOSTIC X-RAY SYSTEM, MODELS MAK 1500, MAK 2000 AND MAK 3000 (October 28, 2008)
  • K080582 — MEDICATECH, MODEL DDR MAK-800, DDT MAK-1000 FS, DDR MAK-1100 FA (May 15, 2008)

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