X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application
FDA 510(k) clearance K243144 · decided 2025-06-27
Clearance details
- K-number
- K243144
- Device name
- X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application
- Applicant
- Scopio Labs , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2024-09-30
- Decision date
- 2025-06-27
- Days to decision
- 270 days
- Clearance type
- Traditional
- Product code
- JOY
- Device class
- 2
- Regulation number
- 864.5260
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Tel Aviv, IL
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| AI100 with Shonit (K221309) | Sigtuple Technologies Pvt. , Ltd. | 2023-09-19 |
| X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) Application (K220013) | Scopio Labs , Ltd. | 2022-05-03 |
| CellaVision DC-1, CellaVision DC-1 PPA (K200595) | CellaVision AB | 2020-10-16 |
| X100 with Full Field Peripheral Blood Smear (PBS) Application (K201301) | Scopio Labs , Ltd. | 2020-10-02 |
| Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device (K182062) | Sysmex America, Inc. | 2018-10-30 |
| Advanced RBC Application (K171315) | CellaVision AB | 2017-08-01 |
| CELLAVISION DM1200 WITH THE BODY FLUID APPLICTION (K102778) | CellaVision AB | 2011-09-16 |
| EASYCELL CELL LOCATOR (K092116) | Medica Corp. | 2010-05-12 |
| CELLAVISION DM1200 AUTOMATED HEMATOLOGY ANALYZER, MODEL XU-10127 (K092868) | CellaVision AB | 2009-11-20 |
| CELLAVISION DM96 WITH THE BODY FLUID APPLICATION (K080595) | CellaVision AB | 2008-12-05 |
| SCANVIEW, MODEL SC-300 (K071398) | Applied Spectral Imaging , Ltd. | 2007-10-04 |
| DUET SYSTEM (K061602) | Bioview , Ltd. | 2007-01-23 |
Recalls involving this device
No recalls on record reference this clearance.