SEARCH RESULTS FOR: (*Sandwhich Panel Machine*)(8781 results)
No Description
iRay Group
Venu1417C-PSI
In Commercial Distribution
- 06970569090061 ()
- 06970569090009 ()
- Indirect flat panel x-ray detector
AcuityDR G4 combines components into a complete digital x-ray system upgrade kit, including software and digital radiography panels. The customer selects one of the following digital x-ray receptor panels: AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717 G4. The solid state imaging receptors can be used in wireless or tethered configuration. The indications for use remain unchanged: Intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammography. So the only difference between this submission and the predicate submission is the available selection of (previously cleared) digital panels. Each system consists of the following items: Customer supplies: Diagnostic x-ray generator (HF) Class I Code IZO. + Tubehead: Class I Code ITV
+ Tube Mount: Class I Code IYB + Attached Collimator, Manual (IZX) Class II 510(k) Exempt We supply: Digital X-Ray Receptor Panel 892.1680 Class II Code MQB. Digital X-ray Software 892.2050 Class II Code LLZ. The software offered for sale with this system has received previous 510(k) clearance in K210919.
We are supplying rebranded versions of the reference devices coupled with the AccuVue software cleared in our predicate K210919.
RADMEDIX, LLC
1
In Commercial Distribution
- 00810035220515 ()
- Indirect flat panel x-ray detector
AcuityDR G4 combines components into a complete digital x-ray system upgrade kit, including software and digital radiography panels. The customer selects one of the following digital x-ray receptor panels: AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717 G4. The solid state imaging receptors can be used in wireless or tethered configuration. The indications for use remain unchanged: Intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammography. So the only difference between this submission and the predicate submission is the available selection of (previously cleared) digital panels. Each system consists of the following items: Customer supplies: Diagnostic x-ray generator (HF) Class I Code IZO. + Tubehead: Class I Code ITV
+ Tube Mount: Class I Code IYB + Attached Collimator, Manual (IZX) Class II 510(k) Exempt We supply: Digital X-Ray Receptor Panel 892.1680 Class II Code MQB. Digital X-ray Software 892.2050 Class II Code LLZ. The software offered for sale with this system has received previous 510(k) clearance in K210919. We are supplying rebranded versions of the reference devices coupled with the AccuVue software cleared in our predicate K210919.
RADMEDIX, LLC
1
In Commercial Distribution
- 00810035220508 ()
- Indirect flat panel x-ray detector
No Description
RADMEDIX, LLC
1
In Commercial Distribution
- 00810035220485 ()
- Indirect flat panel x-ray detector
No Description
RADMEDIX, LLC
1
In Commercial Distribution
- 00810035220447 ()
- Indirect flat panel x-ray detector
The flat panel detector, when used with a radiographic imaging system, is intended to generate radiographic images of human anatomy wherever a conventional screen-film, digital radiography (DR) or computed radiography (CR) detector is used for general purposes.
KA Imaging Inc
1
Not in Commercial Distribution
- 16280119411015 ()
101
- Indirect flat panel x-ray detector
DAU+ V2 F OT
UTAK LABORATORIES, INC.
URINE PAIN PANEL
In Commercial Distribution
- B800DAUV2FOT5 ()
- B800DAUV2FOT0 ()
- Total Volume: 1 Milliliter
URINE PAIN PANEL
- Multiple-type clinical chemistry analyte profile IVD, control
A wound cover extension panel for oversized legs that aids in the extension of the exucare which wraps around the leg which is intended to be used as an initial, short-term treatment after injury that consists of an absorbent pad (e.g., gauze, cotton wool, lint, cellulose) The device is intended for use in the home or a clinical setting to protect wounds, arrest bleeding. This is a single-use device.
SUN SCIENTIFIC, INC.
EC5051
In Commercial Distribution
- 00856525007969 ()
ECX
- First aid absorbent pad/bandage
SHOWER & DISINFECTION PANEL, WHITE, US, with FLUSH VALVE
Arjohuntleigh AB
BCA1224-04
In Commercial Distribution
- 05055982707954 ()
BCA1224-04
- Shower unit
SHOWER & DISINFECTION PANEL, WHITE, US, with FLUSH TANK
Arjohuntleigh AB
BCA1214-04
In Commercial Distribution
- 05055982707916 ()
BCA1214-04
- Shower unit
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BZD / BUP / COC / EDDP / OPI-II / OXY / CREA
RAPID DIAGNOSTICS INC
07RD-7070-21
In Commercial Distribution
- 00817830022887 ()
- Length: 75 Millimeter
07RD-7070-21
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BUP / BZD / COC / M-AMP / MTD / OPI / OXY / THC
RAPID DIAGNOSTICS INC
07RD-7072-10
In Commercial Distribution
- 00817830022870 ()
- Length: 75 Millimeter
07RD-7072-10
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BUP / BZD / COC / EDDP / M-AMP / MTD / OPI / OXY / PCP / THC
RAPID DIAGNOSTICS INC
07RD-7145-03
In Commercial Distribution
- 00817830022856 ()
- Length: 75 Millimeter
07RD-7145-03
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BUP / BZD / MTD / OPI / OXY
RAPID DIAGNOSTICS INC
O7RD-7070-18
In Commercial Distribution
- 00817830022849 ()
- Length: 75 Millimeter
O7RD-7070-18
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BZD / COC / M-AMP / OPI / THC
RAPID DIAGNOSTICS INC
07RD-7070-13
In Commercial Distribution
- 00817830022832 ()
- Length: 75 Millimeter
07RD-7070-13
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BUP / BZD / COC / M-AMP / MTD / OPI / OXY / PCP / THC
RAPID DIAGNOSTICS INC
07RD-7073-08
In Commercial Distribution
- 00817830022801 ()
- Length: 75 Millimeter
07RD-7073-08
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BUP / BZD / COC / OPI / OXY / THC
RAPID DIAGNOSTICS INC
07RD-7070-14
In Commercial Distribution
- 00817830022795 ()
- Length: 75 Millimeter
07RD-7070-14
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: BUP / COC / M-AMP / OPI / OXY / THC
RAPID DIAGNOSTICS INC
07RD-7065-40
In Commercial Distribution
- 00817830022788 ()
- Length: 75 Millimeter
07RD-7065-40
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BUP / BZD / COC / M-AMP / OPI / OXY / PCP / THC
RAPID DIAGNOSTICS INC
07RD-7073-09
In Commercial Distribution
- 00817830022764 ()
- Length: 75 Millimeter
07RD-7073-09
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: BUP / MTD / OPI / OXY
RAPID DIAGNOSTICS INC
07RD-7063-28
In Commercial Distribution
- 00817830022733 ()
- Length: 75 Millimeter
07RD-7063-28
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: BZD / COC / M-AMP / MTD / OPI / OXY
RAPID DIAGNOSTICS INC
07RD-7065-39
In Commercial Distribution
- 00817830022726 ()
- Length: 75 Millimeter
07RD-7065-39
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BZD / COC / MET / OPI / OXY / THC
RAPID DIAGNOSTICS INC
07RD-7070-11
In Commercial Distribution
- 00817830022696 ()
- Length: 75 Millimeter
07RD-7070-11
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BUP / BZD / COC / M-AMP / MTD / OPI-II / PCP / THC
RAPID DIAGNOSTICS INC
07RD-7073-01A
In Commercial Distribution
- 00817830022924 ()
- Length: 75 Millimeter
07RD-7073-01A
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: BZD / OPI-II
RAPID DIAGNOSTICS INC
07RD-7061A
In Commercial Distribution
- 00817830022917 ()
- Length: 75 Millimeter
07RD-7061A
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical
No Description
NICAL SPA
NFP Digital detector
In Commercial Distribution
- 08056600520051 ()
NFPMD4335
- Computed radiography digital imaging scanner
No Description
NICAL SPA
NFP Digital detector
In Commercial Distribution
- 08056600520044 ()
NF3024C00
- Computed radiography digital imaging scanner
ACCESSORY OF
Maestro Control Panel is a physical keyboard to be used to control Inventis audiometers, through Maestro software while performing audiometric exams.
INVENTIS SRL
MAESTRO CONTROL PANEL
In Commercial Distribution
- 08054187380914 ()
12080
- Tone audiometer
No Description
DIASORIN MOLECULAR LLC
EL0950
In Commercial Distribution
- 10816101022202 ()
EL0950
- Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, control
No Description
Aktina Corp.
51-225
In Commercial Distribution
- B365512250 ()
- Indexed-immobilization patient positioning system
The Piccolo® Lipid Panel reagent disc, used with the Piccolo® blood chemistry analyzer or the Piccolo Xpress® Chemistry analyzer, is intended for the in vitro quantitative determination of total cholesterol (CHOL), high-density lipoprotein cholesterol (HDL), and triglycerides (TRIG) in capillary (fingerstick) lithium heparinized whole blood, venous lithium heparinized whole blood, lithium heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. From these determinations low-density lipoprotein cholesterol (LDL), very low-density lipoprotein cholesterol (VLDL), non-HDL cholesterol, and a total cholesterol/high-density lipoprotein cholesterol ratio (TC/H) are calculated by the analyzer.
Lipid measurements are used in the diagnosis and treatment of lipid and lipoprotein disorders, atherosclerosis, various liver and renal diseases, diabetes mellitus, and other diseases involving lipid metabolism or various endocrine disorders.
This test is waived under CLIA ’88 regulations. If a laboratory modifies the test system instructions, then the test is considered high complexity and subject to all CLIA requirements. For CLIA waived labs, only lithium heparin whole blood (venous or capillary) may be tested. For use in moderate complexity labs, lithium heparinized whole blood, lithium heparinized plasma, or serum may be used.
ABAXIS, INC.
400-0025
In Commercial Distribution
- EABA40000251 ()
- EABA40000250 ()
400-0025
- Glucose/ketone/lipid profile IVD, reagent
The Piccolo® Electrolyte Panel, used with the Piccolo® blood chemistry analyzer or the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of chloride, potassium, sodium, and total carbon dioxide in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location.
The tests on this panel are waived under CLIA ’88 regulations. If a laboratory modifies the test system instructions, then the tests are considered high complexity and subject to all CLIA requirements. For CLIA waived labs, only lithium heparin whole blood may be tested. For use in moderate complexity labs, lithium heparinized whole blood, lithium heparinized plasma, or serum may be used.
ABAXIS, INC.
400-0022
In Commercial Distribution
- EABA40000221 ()
- EABA40000220 ()
400-0022
- Chloride (Cl-) IVD, reagent
- Sodium (Na+) IVD, control
- Bicarbonate (HCO3-) IVD, reagent
- Potassium (K+) IVD, reagent
Pregnancy Panel Insert - 0.5mm Regular Lead
Shielding International Inc.
PPIRL
In Commercial Distribution
- G031PPIRL0 ()
- Radiation shielding apron
No Description
MAZOR ROBOTICS LTD
MAS1891-06S
In Commercial Distribution
- 07290115751581 ()
- Stereotactic surgery system probe, reusable
No Description
MAZOR ROBOTICS LTD
MAS1891-04
Not in Commercial Distribution
- 07290109182063 ()
MAS1891-04S
- Stereotactic surgery system probe, reusable
AQUIOS Tetra-2+ Panel CD45-FITC/(CD56 + CD16)-RD1/CD19-ECD/CD3-PC5
BECKMAN COULTER IRELAND INC.
B23534
In Commercial Distribution
- 15099590225735 ()
B23534
- Multiple CD cell marker IVD, antibody
No Description
ASSURE TECH. (HANGZHOU) CO., LTD.
1.0
In Commercial Distribution
- 06952804801823 ()
- Amphetamine-specific IVD, kit, rapid ICT, clinical
No Description
ASSURE TECH. (HANGZHOU) CO., LTD.
1.0
In Commercial Distribution
- 06952804801809 ()
- Opiate/opiate metabolite IVD, kit, rapid ICT, clinical
No Description
ASSURE TECH. (HANGZHOU) CO., LTD.
1.0
In Commercial Distribution
- 06952804801793 ()
- Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
No Description
ASSURE TECH. (HANGZHOU) CO., LTD.
1.0
In Commercial Distribution
- 06952804801779 ()
- Amphetamine-specific IVD, kit, rapid ICT, clinical
No Description
ASSURE TECH. (HANGZHOU) CO., LTD.
1.0
In Commercial Distribution
- 06952804801755 ()
- Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
No Description
ASSURE TECH. (HANGZHOU) CO., LTD.
1.0
In Commercial Distribution
- 06952804801731 ()
- Methadone IVD, kit, rapid ICT, clinical
No Description
ASSURE TECH. (HANGZHOU) CO., LTD.
1.0
In Commercial Distribution
- 06952804801717 ()
- Opiate/opiate metabolite IVD, kit, rapid ICT, clinical
No Description
ASSURE TECH. (HANGZHOU) CO., LTD.
1.0
In Commercial Distribution
- 06952804801816 ()
- Benzodiazepine group IVD, kit, rapid ICT, clinical
No Description
ASSURE TECH. (HANGZHOU) CO., LTD.
1.0
In Commercial Distribution
- 06952804801786 ()
- Phencyclidine (PCP) IVD, kit, rapid ICT, clinical
No Description
ASSURE TECH. (HANGZHOU) CO., LTD.
1.0
In Commercial Distribution
- 06952804801762 ()
- Opiate/opiate metabolite IVD, kit, rapid ICT, clinical
No Description
ASSURE TECH. (HANGZHOU) CO., LTD.
1.0
In Commercial Distribution
- 06952804801748 ()
- Amphetamine-specific IVD, kit, rapid ICT, clinical
No Description
ASSURE TECH. (HANGZHOU) CO., LTD.
1.0
In Commercial Distribution
- 06952804801724 ()
- Opiate/opiate metabolite IVD, kit, rapid ICT, clinical
No Description
ASSURE TECH. (HANGZHOU) CO., LTD.
1.0
In Commercial Distribution
- 06952804801700 ()
- Barbiturate IVD, kit, rapid ICT, clinical
AQUIOS Tetra-1 Panel CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5
BECKMAN COULTER IRELAND INC.
B23533
In Commercial Distribution
- 15099590225704 ()
B23533
- Multiple CD cell marker IVD, antibody
6PLUS1® Multilevel Serum Calibrator Set MassChrom® Steroid Panel 1 and Panel 2
Chromsystems Instruments + Chemicals GmbH
72040
In Commercial Distribution
- 04250317539717 ()
- Total Volume: 3 Milliliter
- 7 Vials
72040
- Multiple steroid hormone IVD, calibrator