FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BSI MODEL MCT 7000-THERMAL IMAGING SYSTEM
K Number: K850534
·
Decision Feb 27, 1985
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
40
Applicant Total
3
Review Days
16
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- BSI MODEL MCT 7000-THERMAL IMAGING SYSTEM
- K Number
- K850534
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 884.2980
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- Bales Scientific, Inc.
- Date Received
- February 11, 1985
- Decision Date
- February 27, 1985
- Product Code
- LHQ
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LHQ | System, Telethermographic (Adjunctive Use) | FDA class 1 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LHQ), ordered by most recent decision date.
Derma-2
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
ThermPix Thermovisual Camera
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
ThermPix Thermovisual Camera
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
Smile-100 System
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
IRIS-XP
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
Thermidas IR System (ThIR-A615)
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology