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Stationary x-ray system intended for obtaining radiographic images portions of the human body in a clinical environment. The device is not intended for mammography.
Arcoma AB
0072
In Commercial Distribution
- 07350008750012 ()
- Stationary basic diagnostic x-ray system, digital
The uDR 596i Radiographic system is intended to be used by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, limbs and trunk. Not for mammography.
UIH TECHNOLOGIES LLC
uDr 596i
In Commercial Distribution
- 00810030350002 ()
- Stationary basic diagnostic x-ray system, analogue
Digital Medical X-ray Imaging System
Shanghai United Imaging Healthcare Co., Ltd.
uDR 596i
In Commercial Distribution
- 06971576833023 ()
- Stationary basic diagnostic x-ray system, digital
Digital Radiographic System
Imaging Dynamics Company Ltd
1800 X4C
In Commercial Distribution
- 00823073061019 ()
- Height: 244 Centimeter
- Stand and Detector Head
- Weight: 875 Kilogram
- Stationary basic diagnostic x-ray system, digital
The Alma Lasers Soprano Titanium Laser System consists of:
•System console (contains the laser diodes, the system software, power supply, andvarious other electronic and mechanical parts)
•Operator control panel with touch-screen technology (GUI)
•Trio applicator with 1064 nm, 810 nm and 755 nm wavelengths applied simultaneously
Premarket Notification Traditional 510(k) Section 8: Page 2 of 4
Alma Lasers Soprano Titanium
• 810 nm applicator
• 755 nm applicator
• Small NIR applicator
• Footswitch and other laser safety accessories
ALMA LASERS LTD.
1
In Commercial Distribution
- 17290110121829 ()
AASP05091845BSR0001
- Dermatological diode laser system
- Intense pulsed light skin surface treatment system
No Description
ALMA LASERS LTD.
1
In Commercial Distribution
- 17290110121812 ()
AASP30111208
- Dermatological diode laser system
- Intense pulsed light skin surface treatment system
The A-Series Spindle Single Flat Panel Monitor is used with the HarmonyAIR A-Series Suspension System.
STERIS CORPORATION
A-Series Suspension System
In Commercial Distribution
- 00724995190309 ()
LAS000007
- Medical monitor/light mount
The Single Flat Panel Monitor Yoke Assembly is used with the HarmonyAIR E-Series Suspension System.
STERIS CORPORATION
E-Series Suspension System
Not in Commercial Distribution
- 00724995171759 ()
10100167
- Medical monitor/light mount
10 Panel Drug Test Cup – AMP, BZO, BUP, COC, MET, MTD, MDMA, OPI, OXY, THC
DEUS VULT, LLC
P33-10-MET
Not in Commercial Distribution
- 00860004081661 ()
- 00860004081654 ()
- 00860004081647 ()
P33-10-MET
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical
MDC-994 9 Panel CLIA Waived Cup (COC300/OPI2000/AMP1000/MET1000/PCP25 /BZO300/BAR300/MTD300/OXY100)
Medical Disposables Corp
MDC-994
In Commercial Distribution
- 00860003196991 ()
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical