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510(k) K230871

EXTRON 5; EXTRON 7 by DRTECH Corporation — Product Code OWB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 17, 2023
Date Received
March 30, 2023
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 DRTECH Corporation

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  • K243443 — EXPD 4343N1; EXPD 4343N; EXPD 4343U1; EXPD 4343NU; EXPD 4343NP; EXPD 3643N1; EXP (March 19, 2025)
  • K242591 — XERO-alpha (November 1, 2024)
  • K242847 — EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi (October 23, 2024)
  • K240243 — EConsole2 (September 23, 2024)
  • K233530 — EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi (July 26, 2024)
  • K232082 — EXPD 4343S (February 13, 2024)
  • K232753 — EXPD 4343D; EXPD 3643D (November 16, 2023)
  • K231225 — EConsole1 (October 18, 2023)

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