FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CRYSTALVIEW T-SERIES COMPUTED RADIOGRAPHY SYSTEM, MODELS T110 (WITH ERASER) AND T100 (WITHOUT ERASER)
K Number: K071682
·
Decision Aug 15, 2007
Classifications
1
FEI Numbers
126
Registration Numbers
126
Same Product Code
422
Applicant Total
6
Review Days
57
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Basic Information
- Device Name
- CRYSTALVIEW T-SERIES COMPUTED RADIOGRAPHY SYSTEM, MODELS T110 (WITH ERASER) AND T100 (WITHOUT ERASER)
- K Number
- K071682
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1680
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Alara, Inc.
- Date Received
- June 19, 2007
- Decision Date
- August 15, 2007
- Product Code
- MQB
- 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 |
|---|---|---|---|
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | FDA class 2 | Radiology |
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Other Clearances by Alara, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K102479 | ALARA T210 COMPUTED RADIOGRAPHY SYSTEM | Jun 2, 2011 | Substantially Equivalent |
| K062390 | CRYSTALVIEW R200 | Sep 18, 2006 | Substantially Equivalent |
| K061538 | ALARA CRYSTALVIEW COMPUTED RADIOGRAPHY SYSTEM, MODEL R200 | Jun 30, 2006 | Substantially Equivalent |
| K032210 | ALARA CRYSTALVIEW COMPUTED RADIOGRAPHY SYSTEM | Oct 2, 2003 | Substantially Equivalent |
| K000162 | METRISCAN BONE DENSITY SYSTEM | May 12, 2000 | Substantially Equivalent |