FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
XR-910
K Number: K981466
·
Decision Jul 14, 1998
Classifications
1
FEI Numbers
77
Registration Numbers
77
Same Product Code
235
Applicant Total
7
Review Days
82
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Basic Information
- Device Name
- XR-910
- K Number
- K981466
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1720
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Imaging Sciences Intl., Inc.
- Date Received
- April 23, 1998
- Decision Date
- July 14, 1998
- Product Code
- IZL
- 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 |
|---|---|---|---|
| IZL | System, X-Ray, Mobile | FDA class 2 | Radiology |
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Other Clearances by Imaging Sciences Intl., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K061284 | I-CAT SCANNER | Jul 3, 2006 | Substantially Equivalent |
| K051980 | DVT SCANNER | Aug 19, 2005 | Substantially Equivalent |
| K041078 | SURGPLAN AND PANPLAN | Dec 23, 2004 | Substantially Equivalent |
| K001248 | MULTI-PULSE 2000 | May 4, 2000 | Substantially Equivalent |
| K991518 | PANATOME | Jun 18, 1999 | Substantially Equivalent |
| K931815 | 2000 X-RAY - TOMOGRAPHIC | Aug 23, 1993 | Substantially Equivalent |