FDA UDI
In Commercial Distribution
🇺🇸 United States
DIGITAL DIAGNOSTICS SYSTEM
DI: 15420045513921
·
Model: INFORMATION MANAGEMENT SYSTEM, BASE
·
Hologic, Inc.
Product Codes
1
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- DIGITAL DIAGNOSTICS SYSTEM
- Primary DI
- 15420045513921
- Version / Model
- INFORMATION MANAGEMENT SYSTEM, BASE
- Catalog Number
- ASY-14305
- Company Name
- Hologic, Inc.
- Labeler DUNS
- 018925968
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-06-07
- Public Version
- 1
- Public Version Date
- 2024-06-17
- Public Version Status
- New
- Public Device Record Key
- cbd5f6b8-a201-41cb-96fe-735a32b0fda2
Device Description
32TB server for use with the Genius™ Digital Diagnostics System for short term digital storage.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QYV | Digital cervical cytology slide imaging system with artificial intelligence algorithm | Pathology | 864.3900 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43472 | Laboratory instrument/analyser application software IVD | An in vitro diagnostic software program intended to be used with an instrument/analyser (e.g., microscope slide digital imaging scanner, immunoassay analyser, real-time PCR machine), or a data management device connected to the instrument/analyser, to: 1) facilitate user-controlled device function [e.g., incubation control]; 2) assist data processing, display, or communication [e.g., image conversion]; and/or 3) produce raw-data-derived qualitative result calculations based on specified criteria [positive or negative assay result]. This software does not use demographic or clinical data to produce a patient score (i.e., it is not interpretive). | No | Active |
| 62575 | Microscope slide digital imaging scanner IVD | A mains electricity (AC-powered) device designed to be used in a histopathology laboratory to scan clinical specimens on microscope slides, at a microscopic level, to produce images in a digital format. Also known as a whole slide scanner or digital pathology slide scanning system, it is a bench-top unit with slide tray slots, high-resolution cameras, a user interface, and integrated software for image creation, viewing, and management to aid the pathologist to review and interpret slide images. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 15420045513921 | GS1 |
Customer Contacts
- Phone
- +1(800)442-9892
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| DEN210035 | 000 |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 15 – 95 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 16 – 32 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- -28 – 50 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 20 – 80 Percent (%) Relative Humidity