Home / 510(k) Clearances / K844916

510(k) K844916

MODEL 518 & 519 ULTRASONOSCOPE W/DOPPLER by Hoffrel Instruments, Inc. — Product Code IYO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 22, 1985
Date Received
December 18, 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 Hoffrel Instruments, Inc.

  • K870850 — MOD 482 (September 8, 1987)
  • K860235 — MOD 426, MEDICAL ULTRASONIC DIAGNOSTC TRANSDUCER (May 15, 1986)
  • K850165 — MOTOR DRIVE, MECHANICAL SECTOR SCANNING-MOD417 (October 23, 1985)
  • K834277 — MOD 427 (February 17, 1984)
  • K834276 — MOD 456 (February 17, 1984)
  • K837282 — MODEL VPS VASCULAR PROFILE SYSTEM (April 26, 1983)
  • K837229 — TRANSDUCER MODELS 450, 451, 452, 453, 454 (April 15, 1983)
  • K837142 — TRANSDUCERS MODELS 421, 419 AND 420 FOR IREX SYSTEM (March 23, 1983)
  • K800364 — ULTRASONIC DIAGNOSTIC SYSTEM, MOD. 202 (March 12, 1980)
  • K790396 — ULTRASONIC DIAGNOSTIC SYSTEM (March 21, 1979)

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)