DXJ · Class II · 21 CFR 870.2450

FDA Product Code DXJ: Display, Cathode-ray Tube, Medical

Leading manufacturers include Hewlett-Packard Co., Siemens Medical Solutions USA, Inc. and Shenyang Torch-Bigtide Digital Technology Co., Ltd..

78
Total
78
Cleared
132d
Avg days
1976
Since
Stable submission activity - 0 submissions in the last 2 years

FDA 510(k) Cleared Display, Cathode-ray Tube, Medical Devices (Product Code DXJ)

78 devices
1–24 of 78
Cleared Nov 10, 2021
ESSENZ Patient Monitor
K212003
Livanova Deutschland, GmbH
Cardiovascular · 135d
Cleared Sep 30, 2021
Philips IntelliVue GuardianSoftware (Rev. E.0X)
K212208
Philips Medizin Systeme Boeblingen GmbH
Cardiovascular · 77d
Cleared Aug 27, 2020
Essence 55SP Large Monitor System
K201162
Shenyang Torch-Bigtide Digital Technology Co., Ltd.
Cardiovascular · 119d
Cleared Jul 26, 2018
Vios Central Station Monitor Software, Vios Central Server Software
K173107
Vios Medical, Inc.
Cardiovascular · 300d
Cleared Jul 16, 2018
Philips IntelliVue GuardianSoftware
K180534
Philips Medizin Systeme Boeblingen GmbH
Cardiovascular · 138d
Cleared Feb 22, 2018
Nexxis OR
K173381
Barco N.V.
Cardiovascular · 115d
Cleared Jan 26, 2018
Essence 55S Large Monitor System
K172969
Shenyang Torch-Bigtide Digital Technology Co., Ltd.
Cardiovascular · 122d
Cleared Jan 10, 2002
INFINITY EXPLORER
K013515
Siemens Medical Solutions USA, Inc.
Cardiovascular · 80d
Cleared Aug 31, 1999
HP CAREVUE 9000 CLINICAL INFORMATION SYSTEM, MODEL M2331A
K992636
Hewlett-Packard Co.
Cardiovascular · 25d
Cleared Jan 30, 1995
HEWLETT-PACKARD MODEL M1490A WIRELESS PATIENT DATA COMMUNICATOR
K945277
Hewlett-Packard Co.
Cardiovascular · 94d
Cleared Jun 06, 1991
MODEL M1251A MON. FULL DISCLOSURE REVIEW SYSTEM
K905788
Hewlett-Packard Co.
Cardiovascular · 161d
Cleared Jun 26, 1985
SIRECUST 420 PATIENT DIALOG MONITOR
K851400
Siemens Medical Solutions USA, Inc.
Cardiovascular · 78d
Cleared Jan 13, 1981
CRT DISPLAY #1310B
K803123
Hewlett-Packard Co.
Cardiovascular · 33d
Cleared May 28, 1980
LARGE SCREEN CRT DISPLAY #1311B
K801000
Hewlett-Packard Co.
Cardiovascular · 33d
Cleared Jun 14, 1978
M. 1336S CATHODE-RAY TUBE DISPLAY
K780782
Hewlett-Packard Co.
Radiology · 33d
Cleared Oct 06, 1976
MEDICAL OSCILLOSCOPE MEMORY SCOPE
K760721
Abbott Laboratories
Cardiovascular · 9d
Cleared Sep 03, 1976
MONITOR SCOPE
K760523
Hewlett-Packard Co.
Cardiovascular · 8d

About Product Code DXJ - Regulatory Context

510(k) Submission Activity

78 total 510(k) submissions under product code DXJ since 1976, with 78 receiving FDA clearance (average review time: 132 days).

Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.