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510(k) K923619

ACCULITE SSL by Medical Alignment Systems — Product Code IWE

K923619 is an FDA 510(k) premarket notification submitted by Medical Alignment Systems for the device "ACCULITE SSL". The FDA issued a decision of Substantially Equivalent on November 16, 1992. The device falls under product code IWE (Monitor, Patient Position, Light-Beam), a Class I device regulated under 21 CFR 892.5780. Medical Alignment Systems has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 1992
Date Received
July 21, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Patient Position, Light-Beam
Device Class
Class I
Regulation Number
892.5780
Review Panel
RA
Submission Type

Other clearances by Medical Alignment Systems

  • K884787 — ACCULITE-PPL 5 (January 24, 1989)
  • K872841 — ACCULITE (August 12, 1987)

Other clearances for product code IWE

  • K152303 — CT Sim Laser System (September 11, 2015)
  • K973162 — DUAL RADIATION TARGETING SYSTEM DRTS DRAPE (November 20, 1997)
  • K955236 — GREEN TEC-2100 (May 24, 1996)
  • K954414 — CENTRALITE BACKPOINTER (October 23, 1995)
  • K950293 — TEC-2110 GREEN LASER MODEL MT-HNG (August 18, 1995)
  • K950112 — CENTRALITE(R)-DLL SERIES (August 16, 1995)
  • K951601 — MED-TEC STRING RETICLE TRAY (May 11, 1995)
  • K943802 — HP BACK POINTER SYSTEM (December 7, 1994)
  • K943381 — LASER ALIGNMENT TOOL (August 9, 1994)
  • K941169 — TEC 2101 (MODEL MT-HPLGD) (July 18, 1994)

FDA data resources