FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
CLEARVISION DR 2000 DIGITAL RADIOGRAPHY X-RAY SYSTEM
K Number: K101779
·
Decision May 16, 2011
Classifications
1
FEI Numbers
81
Registration Numbers
81
Same Product Code
355
Applicant Total
9
Review Days
325
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Basic Information
- Device Name
- CLEARVISION DR 2000 DIGITAL RADIOGRAPHY X-RAY SYSTEM
- K Number
- K101779
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1680
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Jpi Healthcare Co, Ltd.
- Date Received
- June 25, 2010
- Decision Date
- May 16, 2011
- Product Code
- KPR
- 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 |
|---|---|---|---|
| KPR | System, X-Ray, Stationary | FDA class 2 | Radiology |
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Other Clearances by Jpi Healthcare Co, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K260482 | DRE Duo | Jun 15, 2026 | Substantially Equivalent |
| K244010 | ExamVue Apex | Feb 24, 2025 | Substantially Equivalent |
| K213057 | ExamVue Duo | Feb 18, 2022 | Substantially Equivalent |
| K142930 | Exam Vue DR | Apr 17, 2015 | Substantially Equivalent |
| K102327 | CLEARVISION DR 7000F | Apr 13, 2012 | Substantially Equivalent |
| K955706 | JPI AUTOMATIC X-RAY FILM PROCESSOR | Feb 12, 1996 | Substantially Equivalent |
| K954161 | JPI INTENSIFYING SCREEN | Feb 2, 1996 | Substantially Equivalent |
| K950043 | JPI AUTOMATIC X-RAY FILM PROCESSOR | May 10, 1995 | Substantially Equivalent |