Identity
- Trade Name
- Sectra Digital Pathology Module FDA UDI
- Generic Name
- Pathology information system FDA UDI
- Device Name
- For In Vitro Diagnostic Use Sectra Digital Pathology Module device is a software intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It is an aid to the pathologist to review and interpret these digital images for the purposes of primary diagnosis. Sectra Digital Pathology Module is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens. It is the responsibility of the pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images using Sectra Digital Pathology Module. Sectra Digital Pathology Module is intended for use with Leica's Aperio AT2 DX scanner and Dell MR2416 monitor. FDA UDI
- Model / Reference
- 3.3 FDA UDI
- Description
- For In Vitro Diagnostic Use Sectra Digital Pathology Module device is a software intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It is an aid to the pathologist to review and interpret these digital images for the purposes of primary diagnosis. Sectra Digital Pathology Module is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens. It is the responsibility of the pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images using Sectra Digital Pathology Module. Sectra Digital Pathology Module is intended for use with Leica's Aperio AT2 DX scanner and Dell MR2416 monitor. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07350092810456 FDA UDI
- 510(k) Number
- K193054 FDA UDI
- FDA Product Code
- QKQ FDA UDI
- GMDN Term
- Pathology information system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.3700 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Pathology information system
Sectra Digital Pathology Module by Sectra AB — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Pathology information system.
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- Sectra Digital Pathology Module — Sectra AB · Class II
- Sectra Digital Pathology Module — Sectra AB · Class II
- Sectra Digital Pathology Module — Sectra AB · Class II
- Sectra Digital Pathology Module — Sectra AB · Class II
Cleared under the same submission
K193054 also covers:
- Sectra Digital Pathology Module — Sectra AB
- Sectra Digital Pathology Module — Sectra AB
- Sectra Digital Pathology Module — Sectra AB
- Sectra Digital Pathology Module — Sectra AB
- Sectra Digital Pathology Module — Sectra AB
- Sectra Digital Pathology Module — Sectra AB
- Sectra Digital Pathology Module — Sectra AB
- Sectra Digital Pathology Module — Sectra AB
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Sectra AB
Sources (1)
- FDA UDI 970a548e-251e-4160-bf1f-e5d7d1660109 34 fields · synced May 30, 2026