Definition: Intended For Clinical Laboratory Image Storage And Communications. A Clinical Laboratory Image Storage And Communications Device Is A Device That Provides Electronic Storage And Retrieval Functions, And Provides Electronic Transfer For Non-diagnostic
| Device Type ID | 640 |
| Device Name | Digital Image, Storage And Communications, Non-diagnostic, Laboratory Information System |
| Physical State | The Clinical Laboratory Image Storage And Communications Device Is Composed Of The Necessary Hardware And Software For Digital Image Capture And Storage. |
| Technical Method | Allows Users To Receive And Store Documents And Non-diagnostic Clinical Laboratory Digital Images In A Central Repository Or Laboratory Information System (LIS). It Will Allow Users To Scan Any Document For Storage Or Retrieval And May Incorporate OC |
| Target Area | In Vitro |
| Regulation Description | Calculator/data Processing Module For Clinical Use. |
| Regulation Medical Specialty | Clinical Chemistry |
| Review Panel | Clinical Chemistry |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 862.2100 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | NVV |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 640 |
| Device | Digital Image, Storage And Communications, Non-diagnostic, Laboratory Information System |
| Product Code | NVV |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Calculator/data Processing Module For Clinical Use. |
| CFR Regulation Number | 862.2100 [🔎] |
| Device Problems | |
|---|---|
Loss Of Data | 1 |
Data Problem | 1 |
Programming Issue | 1 |
| Total Device Problems | 3 |