FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FTI 100 MEDICAL THERMAL IMAGER
K Number: K862416
·
Decision Jul 1, 1986
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
120
Applicant Total
14
Review Days
6
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Basic Information
- Device Name
- FTI 100 MEDICAL THERMAL IMAGER
- K Number
- K862416
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2040
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Parexel Intl. Corp.
- Date Received
- June 25, 1986
- Decision Date
- July 1, 1986
- Product Code
- LMC
- Advisory Committee
- Radiology
- 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 |
|---|---|---|---|
| LMC | Camera, Multi Format, Radiological | FDA class 2 | Radiology |
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Other Clearances by Parexel Intl. Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K900385 | ACTA METRA/ACTA GNOSIS FIRMWARE PACKAGE | Jul 9, 1991 | Substantially Equivalent |
| K904901 | L11, L12 LINEAR AND C11, C12 CONVEX ARRAY TRANSDUC | Mar 26, 1991 | Substantially Equivalent |
| K904902 | SMA 26 TRANSDUCER | Mar 26, 1991 | Substantially Equivalent |
| K884800 | ACTA GENOS ELECTROCARDIOGRAPH | Jun 22, 1989 | Substantially Equivalent |
| K862414 | FUJI CR IMAGING PLATE | Feb 26, 1987 | Substantially Equivalent |
| K864519 | PHILIPS COMPUTED RADIOGRAPHY SYSTEM (PCR) | Feb 13, 1987 | Substantially Equivalent |
| K862415 | TYPE 633 COMPUTED RADIOGRAPHY (CR) FILM | Jul 1, 1986 | Substantially Equivalent |
| K853295 | EMODREN EXCHANGEABLE PLASTIC BELLOWS | Aug 20, 1985 | Substantially Equivalent |
| K853296 | EMODREN GUIDE NEEDLE FOR DRAINAGE TUBE & EMODREN | Aug 15, 1985 | Substantially Equivalent |
| K851322 | PERSONAL C3 3-CHANNEL ELECTROCARDIOGRAPH | May 16, 1985 | Substantially Equivalent |