FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
POLYSCAN DIGITAL SCANNER
K Number: K882453
·
Decision Nov 23, 1988
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
3
Applicant Total
5
Review Days
162
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Basic Information
- Device Name
- POLYSCAN DIGITAL SCANNER
- K Number
- K882453
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.1300
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Medical and Scientific Enterprises, Inc.
- Date Received
- June 14, 1988
- Decision Date
- November 23, 1988
- Product Code
- IYW
- 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 |
|---|---|---|---|
| IYW | Scanner, Rectilinear, Nuclear | FDA class 1 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IYW), ordered by most recent decision date.
POLYSCAN DIGITAL SCANNER
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RECTILINEAR SCANNER MODEL #187-270
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IMAGER, BODY SECTION, RADIONUCLIDE
FDA 510(k)
FDA Class 1
·Radiology
Other Clearances by Medical and Scientific Enterprises, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K933131 | BISTAT 70/70-I ELECTROSURGICAL UNIT | Feb 15, 1994 | Substantially Equivalent |
| K913881 | ENDOSTAT ELECTROSURGICAL UNIT | Nov 1, 1991 | Substantially Equivalent |
| K895855 | PHOENIX | Jan 22, 1990 | Substantially Equivalent |
| K861233 | DUAL PHOTON BONE DENSITOMETER | Mar 3, 1987 | Substantially Equivalent |