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510(k) K091628

OPTIMAX, COMPACT 2, OPTIMAX 2010, ECOMAX by Protec GmbH & Co. KG — Product Code IXW

K091628 is an FDA 510(k) premarket notification submitted by Protec GmbH & Co. KG for the device "OPTIMAX, COMPACT 2, OPTIMAX 2010, ECOMAX". The FDA issued a decision of Substantially Equivalent on August 21, 2009. The device falls under product code IXW (Processor, Radiographic-Film, Automatic), a Class II device regulated under 21 CFR 892.1900. Protec GmbH & Co. KG has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 21, 2009
Date Received
June 4, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Processor, Radiographic-Film, Automatic
Device Class
Class II
Regulation Number
892.1900
Review Panel
RA
Submission Type

Other clearances by Protec GmbH & Co. KG

  • K992818 — OPTIMAX/ COMPACT 2 (September 1, 1999)

Other clearances for product code IXW

  • K111167 — XTENDER FILM PROCESSOR, SPRINT FILM PROCESSOR MODEL XTENDER MODEL SPRINT (August 18, 2011)
  • K093503 — INTRAX FILM PROCESSOR (January 6, 2010)
  • K024342 — RADIOGRAPHIC FILM PROCESSOR, MODELS XP400 AND XP1000 (April 23, 2003)
  • K023801 — FILM PROCESSOR, MODEL LIFE RAY PRO 1000 (February 12, 2003)
  • K023825 — FILM PROCESSOR, MODEL LIFE RAY PRO 2500 (February 12, 2003)
  • K023613 — AX200 AUTOMATIC X-RAY FILM PROCESSOR, MODEL 6586.036 (January 23, 2003)
  • K022154 — LEVEL 356 X-RAY FILM PROCESSOR, MODELS MD & MD-D (September 30, 2002)
  • K002640 — FREEDOM AUTOMATIC FILM PROCESSOR (November 8, 2000)
  • K002404 — MICRO-MAX, MODEL 319 (August 30, 2000)
  • K001321 — ALL-PRO 2010 (May 16, 2000)

FDA data resources