510(k) K101641
- Device
- AG THERMOGRAPHIC CAMERA, MODEL ATIR-M301
- Applicant
- AG DIGITAL TECHNOLOGY CORP.
- 510(k) number
- K101641
- Product code
- LHQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2011-06-16
- Date received
- 2010-06-10
- 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
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JENNIFER REICH
- Address
- 2904 N. Boldt Dr. Flagstaff AZ US 86001 86001
FDA Registration Numbers#
- 3041915306
- 3007010903
- 3013951855
- 3006033213
- 3007420760
- 3018553169
- 1933956
- 3010914393
- 2000010846
- 3015414274
- 3017970306
- 3006111110
Source Documents#
Other 510(k) Records For Product Code LHQ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253911 | Derma-2 | Neko Health AB | 2026-05-20 |
| K232462 | ThermPix Thermovisual Camera | Usa Therm, Inc. | 2023-09-14 |
| K213650 | ThermPix Thermovisual Camera | Usa Therm, Inc. | 2022-04-12 |
| K212965 | Smile-100 System | Niramai Health Analytix Private Limited | 2022-03-10 |
| K212412 | IRIS-XP | Medicore Co., Ltd. | 2021-09-13 |
| K200999 | Thermidas IR System (ThIR-A615) | Thermidas Americas, Inc. | 2021-01-06 |
| K181716 | InTouch Thermal Camera | Intouch Technologies, Inc., D.B.A. Intouch Health | 2019-03-25 |
| 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 |
| 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 |
| K050239 | EMD THERMOGRAPHY SYSTEM | Em Diagnostics, Inc. | 2006-03-16 |
Legacy Summary#
summary
FDA Review#
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