510(k) K020783
- Device
- TELESIS DIGITAL INFRARED THERMAL IMAGE SYSTEM, SPECTRUM 9000MB
- Applicant
- TELESIS TECHNOLOGIES INC.
- 510(k) number
- K020783
- Product code
- LHQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-06-07
- Date received
- 2002-03-11
- Regulation
- 884.2980
- Classification name
- System, Telethermographic (adjunctive Use)
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Radiology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- Ke-Min Jen
- Address
- 14f-3 & -4, #81, Sec 1, Hsin-Tai-Wu Rd. His-Chih City, Taipei Hsien TW 221 221
FDA Registration Numbers#
- 3041915306
- 3007010903
- 3013951855
- 3006033213
- 3007420760
- 3018553169
- 1933956
- 3010914393
- 2000010846
- 3015414274
- 3017970306
- 3006111110
Source Documents#
510(k) summary PDF not indicated by FDA
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| K171928 | Med-Hot Thermal Imaging Systems | Med-Hot Thermal Imaging, Inc. | 2017-12-08 |
| K162767 | Sentinel BreastScan II System | First Sense Medical, LLC | 2017-01-09 |
| K160573 | FirstSense Breast Exam | First Sense Medical, LLC | 2016-06-01 |
| K150457 | AlfaSight 9000 Thermographic System | Alfa Thermodiagnostics, Inc. | 2015-04-10 |
| K113259 | NOTOUCH BREASTSCAN | Ue Lifesciences, Inc. | 2012-02-10 |
| K101641 | AG THERMOGRAPHIC CAMERA, MODEL ATIR-M301 | Ag Digital Technology Corp. | 2011-06-16 |
| K073581 | ICI P AND S SERIES IR CAMERAS | Texas Infrared | 2008-07-11 |
| K063047 | MEDHOT MTI 2000 THERMAL IMAGING SYSTEM | Medhot Thermal Imaging, Inc. | 2006-10-19 |
Legacy Summary#
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FDA Review#
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