FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INFISTITCH FOR I5 DIGITAL X-RAY IMAGING SYSTEM, MODEL I5
K Number: K101833
·
Decision Jul 23, 2010
Classifications
1
FEI Numbers
118
Registration Numbers
118
Same Product Code
319
Applicant Total
14
Review Days
22
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Basic Information
- Device Name
- INFISTITCH FOR I5 DIGITAL X-RAY IMAGING SYSTEM, MODEL I5
- K Number
- K101833
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.1650
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Infimed, Inc.
- Date Received
- July 1, 2010
- Decision Date
- July 23, 2010
- Product Code
- OWB
- 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 |
|---|---|---|---|
| OWB | Interventional Fluoroscopic X-Ray System | FDA class 2 | Radiology |
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Other Clearances by Infimed, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K112180 | I5 DIGITAL X-RAY IMAGING SYSTEM (WITH SDX-4336CP) | Aug 10, 2011 | Substantially Equivalent |
| K111344 | I5 DIGITAL X-RAY IMAGING SYSTEM (WITH FLAATZ 560) | Jun 10, 2011 | Substantially Equivalent |
| K103416 | NEXUS DRF DIGITAL X-RAY IMAGING SYSTEM | Mar 17, 2011 | Substantially Equivalent |
| K093066 | I5 DIGITAL X-RAY IMAGING SYSTEM, MODEL I5 | Mar 16, 2010 | Substantially Equivalent |
| K012490 | ORION DIGITAL IMAGING SYSTEM | Feb 12, 2002 | Substantially Equivalent |
| K992392 | RTLX | Mar 31, 2000 | Substantially Equivalent |
| K992794 | STINGRAY DR, MODEL 1 | Nov 9, 1999 | Substantially Equivalent |
| K992575 | CARDIOVASCULAR WORKSTATION, MODEL CWS 5000/CWS 3000 | Oct 7, 1999 | Substantially Equivalent |
| K962422 | INFIMED DENTAL SYSTEM | Sep 11, 1997 | Substantially Equivalent |
| K963037 | PATRIOT | Sep 27, 1996 | Substantially Equivalent |