POLYSCAN DIGITAL SCANNER
FDA 510(k) clearance K944684 · decided 1995-05-15
Clearance details
- K-number
- K944684
- Device name
- POLYSCAN DIGITAL SCANNER
- Applicant
- Mse Medizintechnik GmbH & Co. KG
- Decision
- Substantially Equivalent
- Date received
- 1994-09-22
- Decision date
- 1995-05-15
- Days to decision
- 235 days
- Clearance type
- Traditional
- Product code
- IYW
- Device class
- 1
- Regulation number
- 892.1300
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Rodemark, DE
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| RECTILINEAR SCANNER MODEL #187-270 (K895799) | Atomic Products Corp. | 1990-02-01 |
| POLYSCAN DIGITAL SCANNER (K882453) | Medical and Scientific Enterprises, Inc. | 1988-11-23 |
| IMAGER, BODY SECTION, RADIONUCLIDE (K780395) | Union Carbide Corp. | 1978-03-31 |
Recalls involving this device
No recalls on record reference this clearance.