Dgh-500 Pachymeter

510(k) Number

K920906 ↗

FDA product code

IYO

FDA applicant

Dgh Technology, Inc.

Device class

Class II

Regulation

21 CFR Part 892.1560

Advisory committee

Radiology

FDA decision

SESE Substantially Equivalent

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Other devices filed under FDA product code IYO (System, Imaging, Pulsed Echo, Ultrasonic).

• QUANTUM QAD-1E ANGIODYNOGRAPH ULTRASOUND SYSTEM by Quantum Intl.
• DIAGNOSTIC ULTRASOUND SYSTEM MODEL SC480 by Pie Medical Equipment B.V.
• CIVCO SCAN DRAPE by CIVCO MEDICAL INSTRUMENTS CO., INC.
• EUB-310 ULTRASONIC SCANNER by Hitachi Medical Corp. of America
• PORTABLE MEDICAL ULTRASOUND SCANNER by Bion Ent., Ltd.
• OPTIONAL PROBE OF CANON IOL ESTIMATOR KU-1 by Canon USA, Inc.
• SONOLINE CF by Siemens Ultrasound, Inc.
• DERMASCAN C, AN ULTRASONIC DIAGNOSTIC SYSTEM by Brymill Corp.
• FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+) by ECHOSENS
• B-Scan by Accutome, Inc. Doing Business AS Keeler USA

• DGH 1006 Corded Pachymeter Probe

  Class II

  FDA 510(k) K920906 Active Cleared 2 Nov 1992 GUDID on market

• DGH 2006 Corded Pachymeter Probe

  Class II

  FDA 510(k) K920906 Active Cleared 2 Nov 1992 GUDID on market

• Scanmate B DGH 8000

  Class II

  CE/MDD FDA 510(k) K070907 Active Cleared 17 Apr 2007 +1authorizations

• Multiple Measurement Calbox MM Calbox

  Class II

  FDA 510(k) K920906 Active Cleared 2 Nov 1992 GUDID on market

See all devices from Dgh Technology Inc. →