HOLOGIC CER 20/20, COMPUTED EQUAL RADIO DIAG CHEST— 510(k) K913757

Name: FDA 510(k) clearance K913757
Creator: U.S. Food and Drug Administration
Published: 1991-10-30

Substantially Equivalent

Hologic, Inc.

FDA 510(k) clearance K913757 for HOLOGIC CER 20/20, COMPUTED EQUAL RADIO DIAG CHEST, Substantially Equivalent on 1991-10-30. Applicant: Hologic, Inc.. Device class: 2.

Clearance details

Applicant: Hologic, Inc.
Product code: Code KPR
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 1991-08-21
Decision date: 1991-10-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waltham, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KPR

view all

K260227 — EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS DEXi-S40T); EXSYS DEXi (EXSYS DEXi-S50H2026-09-08
K260488 — MULTIX Impact; MULTIX Impact C2026-08-31
K260481 — GC85A2026-08-27
K260482 — DRE Duo2026-06-15
K253446 — AeroDR TX c022026-04-10

More clearances from Hologic, Inc.

view all

K254090 — I-View®2026-09-02
K262792 — Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09)2026-08-12
K253634 — CoolSeal Generator® (CSL-200-90)2026-06-17
K251993 — Panther Fusion GI Expanded Bacterial Assay2025-09-25
K243341 — Genius AI Detection 2.02025-07-31

Adverse events under product code KPR

product code KPR

Other: 6
Total: 6

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.