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510(k) K042733

STANDARD IMAGING PIPSPRO QA SOFTWARE SYSTEM by Standard Imaging, Inc. — Product Code LHO

K042733 is an FDA 510(k) premarket notification submitted by Standard Imaging, Inc. for the device "STANDARD IMAGING PIPSPRO QA SOFTWARE SYSTEM". The FDA issued a decision of Substantially Equivalent on November 15, 2004. The device falls under product code LHO (Instrument, Quality-Assurance, Radiologic), a Class I device regulated under 21 CFR 892.1940. Standard Imaging, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 15, 2004
Date Received
October 1, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Quality-Assurance, Radiologic
Device Class
Class I
Regulation Number
892.1940
Review Panel
RA
Submission Type

Other clearances by Standard Imaging, Inc.

  • K103193 — DOSEVIEW 3D (December 27, 2010)
  • K082773 — STANDARD IMAGING IMSURE BRACHY QA SOFTWARE, MODEL 91331 (November 19, 2008)
  • K060532 — HDR 1000 PLUS WELL CHAMBER, MODEL 90008 (April 11, 2006)
  • K040688 — STANDARD IMAGING E.IMRT CALCULATOR (May 11, 2004)
  • K013548 — STANDARD IMAGING IVB 1000 WELL CHAMBER (November 9, 2001)
  • K002833 — MODIFICATION TO STANDARD IMAGING PT 1000 ION CHAMBER (September 28, 2000)
  • K001825 — STANDARD IMAGING HDR 1000 PLUS ION CHAMBER; STANDARD IMAGING IVB 1000 ION CHAMBE (August 2, 2000)
  • K940539 — STAND IMAGING DOSE CALIBRATOR SHIELDED WORK PLATFORM (March 16, 1994)
  • K922554 — STANDARD IMAGING HDR 1000 ION CHAMBER (August 24, 1992)

Other clearances for product code LHO

  • K873956 — ULTIMETER (October 30, 1987)
  • K860260 — MULTI PURPOSE MODEL 76-903 (May 7, 1986)
  • K853754 — MAGNETIC RESONANCE IMAGING UNIFORMITY/T1 76-901 (May 7, 1986)
  • K860100 — MRI SLICE THICKNESS & CONTIGUITY PHANTOM #76-902 (April 22, 1986)
  • K845007 — RFA-7 RADIATION FIELD ANALYZER (July 1, 1985)
  • K844620 — BDS-3 BEAM DATA SCANNER (July 1, 1985)
  • K834483 — DIGI-X (March 5, 1984)

FDA data resources