FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MAMMOTEST PRODUCT, MODIFICATION
K Number: K926575
·
Decision Mar 30, 1993
Classifications
1
FEI Numbers
60
Registration Numbers
60
Same Product Code
189
Applicant Total
69
Review Days
119
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
- MAMMOTEST PRODUCT, MODIFICATION
- K Number
- K926575
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.1800
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Fischer Imaging Corp.
- Date Received
- December 1, 1992
- Decision Date
- March 30, 1993
- Product Code
- EHD
- Advisory Committee
- Dental
- 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 |
|---|---|---|---|
| EHD | Unit, X-Ray, Extraoral With Timer | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EHD), ordered by most recent decision date.
Portable Dental X-ray System Model PDX nova
FDA 510(k)
FDA Class 2
·Dental
NOMAD Pro 3
FDA 510(k)
FDA Class 2
·Dental
Dental X-RAY Unit (AJX200)
FDA 510(k)
FDA Class 2
·Dental
Portable Dental X-ray Device (GT-1)
FDA 510(k)
FDA Class 2
·Dental
Diagnostic X-Ray Equipment Model POCT22
FDA 510(k)
FDA Class 2
·Dental
Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray )
FDA 510(k)
FDA Class 2
·Dental
Other Clearances by Fischer Imaging Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K042095 | MAMMOTEST | Oct 29, 2004 | Substantially Equivalent |
| K021113 | MAMMOPATH | Jun 13, 2002 | Substantially Equivalent |
| K981414 | LC POSITIONER | Jul 16, 1998 | Substantially Equivalent |
| K973400 | MAMMOTEST ADAPTER DRIVER | Nov 10, 1997 | Substantially Equivalent |
| K964806 | MD-1835 | Mar 4, 1997 | Substantially Equivalent |
| K961207 | EP-X BIPLANE | Aug 20, 1996 | Substantially Equivalent |
| K961022 | TANGENT VI TABLE | May 3, 1996 | Substantially Equivalent |
| K950291 | DIGITAL 625HF | Mar 23, 1995 | Substantially Equivalent |
| K945619 | ATHENA HFX | Mar 23, 1995 | Substantially Equivalent |
| K944147 | MICRO X-50 HF | Sep 16, 1994 | Substantially Equivalent |