Clearvision DR 7000F
FDA 510(k) K102327 · Jpi Healthcare Co, Ltd.
510(k) numberK102327
Submission
- Device name
- Clearvision DR 7000F
- Applicant
- Jpi Healthcare Co, Ltd.
Seoul, KR - Received
- August 17, 2010
- Decision date
- April 13, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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|---|---|---|---|
| K253800 | 0909FCE, 0909FCE-HSMQB · Traditional | Rayence Co., Ltd. | 07/31/2026SE |
| K260820 | Vivix-S 4386W (FXRD-4386WA)MQB · Special | Vieworks Co., Ltd. | 06/18/2026SE |
| K252996 | Universal 1417PIMQB · Abbreviated | Konica Minolta Healthcare Americas, Inc. | 06/12/2026SE |
| K252911 | Lux HD 2530 detector (Lux HD 2530)MQB · Special | Iray Imaging Technology (Haining) Limited | 10/09/2025SE |
| K250211 | Yushan X-Ray Flat Panel DetectorMQB · Traditional | Innocare Optoelectronics Corp. | 07/22/2025SE |
| K250665 | SKR 3000MQB · Traditional | Konica Minolta, Inc. | 06/17/2025SE |
| K243734 | Wireless/ Wired X-Ray Flat Panel DetectorsMQB · Special | Allengers Medical Systems Limited | 04/18/2025SE |
| K242770 | Expd 114; Expd 114G; Expd 114P; Expd 114PGMQB · Special | DRTECH Corporation | 03/20/2025SE |
| K243443 | Expd 4343N1; Expd 4343N; Expd 4343U1; Expd 4343NU; Expd 4343NP; Expd 3643N1; Expd 3643N…MQB · Special | DRTECH Corporation | 03/19/2025SE |
| K243556 | Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43)MQB · Traditional | Iray Imaging Technology (Haining) Limited | 03/18/2025SE |
More from Iray Imaging Technology (Haining) Limited
| 510(k) | Device | Decision |
|---|---|---|
| K260482 | DRE DuoKPR · Traditional | 06/15/2026SE |
| K244010 | ExamVue ApexMQB · Traditional | 02/24/2025SE |
| K213057 | ExamVue DuoKPR · Traditional | 02/18/2022SE |
| K160143 | ClearVision ExamVue Flat Panel DetectorMQB · Traditional | 10/28/2016SE |
| K142930 | Exam Vue DRKPR · Traditional | 04/17/2015SE |
| K101779 | Clearvision DR 2000 Digital Radiography X-Ray SystemKPR · Traditional | 05/16/2011SE |
| K955706 | Jpi Automatic X-Ray Film ProcessorIXW · Traditional | 02/12/1996SE |
| K954161 | Jpi Intensifying ScreenEAM · Traditional | 02/02/1996SE |
| K950043 | Jpi Automatic X-Ray Film ProcessorIXW · Traditional | 05/10/1995SE |
Questions and answers
When was Clearvision DR 7000F cleared by the FDA?
Clearvision DR 7000F (K102327) received a 510(k) decision of Substantially Equivalent on April 13, 2012, 605 days after the submission was received.
What is the product code of K102327?
The FDA product code is MQB – Solid State X-Ray Imager (Flat Panel/Digital Imager), a Class II (moderate risk) device regulated under 21 CFR 892.1680.