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433
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2828
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2403
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Polymer Patient Examination Glove
407
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381
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358
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351
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301
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284
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Automated Radiological Image...
275
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269
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Orthopedic Stereotaxic Instrument
226
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Intervertebral Fusion Device...
209
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Iray Imaging Technology (Haining) Limited
Medical Device Manufacturer
·
CN , Haining
Iray Imaging Technology (Haining) Limited - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2023
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Iray Imaging Technology (Haining) Limited
Radiology
✕
4
devices
1-4 of 4
Filters
Cleared
Oct 09, 2025
Lux HD 2530 detector (Lux HD 2530)
K252911
·
MQB
Radiology
·
27d
Cleared
Mar 18, 2025
Lux HD 35 Detector (Lux HD 35)
K243556
·
MQB
Radiology
·
120d
Cleared
Oct 20, 2023
Digital Wireless Intraoral X-Ray Sensor
K230998
·
MUH
Radiology
·
196d
Cleared
Apr 21, 2023
Digital Intraoral X-Ray Sensor
K230811
·
MUH
Radiology
·
28d
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4
Radiology
4