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510(k) K042733

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

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

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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)