FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MAMEX DC MAG MG12
K Number: K881506
·
Decision Jun 10, 1988
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
175
Applicant Total
21
Review Days
60
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Basic Information
- Device Name
- MAMEX DC MAG MG12
- K Number
- K881506
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1710
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Orion Corp.
- Date Received
- April 11, 1988
- Decision Date
- June 10, 1988
- Product Code
- IZH
- 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 |
|---|---|---|---|
| IZH | System, X-Ray, Mammographic | FDA class 2 | Radiology |
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Other Clearances by Orion Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K912391 | RUBALEX, MODIFICATION | May 4, 1992 | Substantially Equivalent |
| K901637 | RESUBMITTED MODIFIED RUBALEX | Apr 26, 1990 | Substantially Equivalent |
| K884650 | RESUBMITTED SCANORA | Mar 16, 1989 | Substantially Equivalent |
| K890199 | DENTOCULT SM-STRIP MUTANS | Mar 2, 1989 | Substantially Equivalent |
| K881505 | MAMEX DC MG11 | Jun 10, 1988 | Substantially Equivalent |
| K874040 | MAMEX DC S SL10/MG14 | Nov 23, 1987 | Substantially Equivalent |
| K872744 | MODIFIED CHLAMYSET ANTIGEN | Sep 22, 1987 | Substantially Equivalent |
| K872301 | DENTOCULT-SM CULTURE-PADDLE | Sep 11, 1987 | Substantially Equivalent |
| K864457 | CHLAMYSET ANTIBODY EIA | Sep 11, 1987 | Substantially Equivalent |
| K872058 | ORICULT-N CULTURE-PADDLE | Jun 10, 1987 | Substantially Equivalent |