Home / 510(k) Clearances / K842127

510(k) K842127

AMERICAN MEDICAL OPTICS IMAGING SYS by American Medical Optics — Product Code IYO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 7, 1984
Date Received
May 29, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Imaging, Pulsed Echo, Ultrasonic
Device Class
Class II
Regulation Number
892.1560
Review Panel
RA
Submission Type

Other clearances by American Medical Optics

  • K860001 — BARRAQUER-KRUMEICH REFRACTIVE SET (February 4, 1986)
  • K851264 — AMER. MEDICAL OPTICS MONOCULAR INDIRECT OPHTHALMAS (May 1, 1985)
  • K851263 — AMER. MEDICAL OPTIC MONOCULAR DIRECT OPHTHALMASCOP (May 1, 1985)
  • K851262 — AMER. MEDICAL OPTICAL BINOCULAR INDIRECT OPHTHALMA (April 30, 1985)
  • K844150 — MEDICAL OPTICS PHACOEMULSIFICATION KIT (December 11, 1984)
  • K843966 — ARGON/KRYPTON LASER PHOTOCOAGULATOR SYS (November 8, 1984)
  • K843965 — ARGON LASER PHOTOCOAGULATOR SYS (November 6, 1984)
  • K842197 — AMERICAN MEDICAL OPTICS I/A KIT- IRRIG (October 1, 1984)
  • K842504 — AMER. MEDICAL OPTICS DIGITAL KERATO- (October 1, 1984)
  • K842251 — AMERI. MEDICAL OPTICS ARGON LASER PHOTO (August 15, 1984)

Other clearances for product code IYO

  • K253898 — QT Scanner 2000 Model A (March 4, 2026)
  • K253714 — IntraSight Plus (February 24, 2026)
  • K253221 — Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro) (February 6, 2026)
  • K250331 — Astrasono A3Pro Bladder Scanner (A3Pro) (September 30, 2025)
  • K250381 — Deepsight NeedleVue LC1 Ultrasound System (August 1, 2025)
  • K243227 — B-Scan (July 11, 2025)
  • K251728 — Velacur One (LI-1100) (June 26, 2025)
  • K243880 — Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini (June 17, 2025)
  • K243937 — Accuro 3S (May 23, 2025)
  • K243479 — EchoGuide (Version 1) (April 23, 2025)