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510(k) K011273

SI ASCOPE by Astron Clinica Limited — Product Code PSN

K011273 is an FDA 510(k) premarket notification submitted by Astron Clinica Limited for the device "SI ASCOPE". The FDA issued a decision of Substantially Equivalent on February 20, 2002. The device falls under product code PSN (Light Based Imaging), a Class II device regulated under 21 CFR 878.4580. Astron Clinica Limited has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 20, 2002
Date Received
April 26, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light Based Imaging
Device Class
Class II
Regulation Number
878.4580
Review Panel
SU
Submission Type

Emission and collection of light to create an image for medical purposes

Other clearances by Astron Clinica Limited

  • K062736 — SIASCOPE V (September 14, 2007)
  • K023729 — SIASCOPE II (February 3, 2003)

Other clearances for product code PSN

  • K230448 — DeepX DermoSight Dermatoscope (May 17, 2023)
  • K213957 — Demetra Dermatoscope BDEM-01 (March 11, 2022)
  • K201408 — Demetra Analytics Toolkit (February 18, 2021)
  • K192829 — Demetra BDEM-01 Dermatoscope (December 13, 2019)
  • K180162 — VivaScope System (May 3, 2018)
  • K080788 — VIVASCOPE SYSTEM, MODEL 1500, 3000 (September 17, 2008)
  • K062736 — SIASCOPE V (September 14, 2007)
  • K040171 — MICRODERM, MODEL/VERSION 3.5 (June 8, 2004)
  • K023729 — SIASCOPE II (February 3, 2003)

FDA data resources