FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇮 Finland
PLANMED SOPHIE
K Number: K904953
·
Decision Apr 18, 1991
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
175
Applicant Total
13
Review Days
164
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Basic Information
- Device Name
- PLANMED SOPHIE
- K Number
- K904953
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1710
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Planmeca USA, Inc.
- Date Received
- November 5, 1990
- Decision Date
- April 18, 1991
- 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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| K Number | Device Name | ||
|---|---|---|---|
| K111361 | PLANMED NUANCE EXCEL | Sep 23, 2011 | Substantially Equivalent |
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| K923534 | PM2002 PROLINE | Jan 31, 1994 | Substantially Equivalent |
| K923533 | ADMARK | Mar 4, 1993 | Substantially Equivalent |
| K923462 | DELIGHT | Dec 21, 1992 | Substantially Equivalent |
| K923461 | PM2002 PROLINE, PM2002 PROLINE EC | Dec 21, 1992 | Substantially Equivalent |
| K904947 | PM2002 CC, ARISTOCRAT AND ARISTOCRAT DELUXE | Jan 30, 1991 | Substantially Equivalent |
| K904948 | PM2002 CC AND PM2002 EC | Jan 30, 1991 | Substantially Equivalent |
| K864474 | DENTAL RADIOGRAPHIC 90, MODEL PM 2002 CC PANORAMIC | Nov 26, 1986 | Substantially Equivalent |
| K842359 | AUTOMATIC PATIENT CHAIR PM2000 & A | Sep 19, 1984 | Substantially Equivalent |