FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MTS-007, STS-008, SSMTS-010, EURO-40, 72, SUPER EURO 4072, 5000
K Number: K946261
·
Decision Feb 15, 1995
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
39
Applicant Total
7
Review Days
64
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Basic Information
- Device Name
- MTS-007, STS-008, SSMTS-010, EURO-40, 72, SUPER EURO 4072, 5000
- K Number
- K946261
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.1770
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Scott Imaging Intl., Inc.
- Date Received
- December 13, 1994
- Decision Date
- February 15, 1995
- Product Code
- IYB
- 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 |
|---|---|---|---|
| IYB | Tube Mount, X-Ray, Diagnostic | FDA class 1 | Radiology |
Similar 510(k) Clearances
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Other Clearances by Scott Imaging Intl., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K946260 | NTBS-1417, 1436, TBS-1417 | Mar 31, 1995 | Substantially Equivalent |
| K950040 | SII 525 APR | Mar 21, 1995 | Substantially Equivalent |
| K950041 | SII 360 APR | Mar 21, 1995 | Substantially Equivalent |
| K946262 | EURO, SCST, SCCFT ATLAS RADIOLOGIC TABLES | Feb 15, 1995 | Substantially Equivalent |
| K945709 | SII 525 MS | Dec 14, 1994 | Substantially Equivalent |
| K945708 | SII 360 MS | Dec 14, 1994 | Substantially Equivalent |