510(k) clearances

Concentriq AP-Dx

Proscia, Inc. · Pathology

K261380Substantially EquivalentTraditionalQKQ
Open FDA's page for this record
Third party flag
N
City
Philadelphia
Advisory committee description
Pathology
Address 1
1700 Market St.
Address 2
Floor 24
Statement or summary
Summary
Product code
QKQ
Zip code
19103
Applicant
Proscia, Inc.
Decision date
2026-08-05
Decision code
SESE
Country code
US
Device name
Concentriq AP-Dx
Advisory committee
PA
Contact
Ian Cadieux
K number
K261380
State
PA
Date received
2026-04-27
Review advisory committee
PA
Postal code
19103
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Digital Pathology Image Viewing And Management Software
Medical specialty description
Pathology
Regulation number
864.3700
Device class
2
Registration number
3020687180, 3039404341, 3026040791, 3017125738, 3025774973, 3003989064, 9615992, 3006791373, 3039498387, 3031081536, 3003584784, 3008491142
FEI number
3020687180, 3039404341, 3026040791, 3017125738, 3025774973, 3003989064, 3006791373, 3039498387, 3031081536, 3003584784, 3001104292, 3008491142
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.