Atlas FDA

VIRTUOSO SYSTEM FOR IHC P53 (DO-7)

FDA 510(k) clearance K111872 · decided 2012-04-19

Clearance details

K-number
K111872
Device name
VIRTUOSO SYSTEM FOR IHC P53 (DO-7)
Applicant
Ventana Medical Systems, Inc.
Decision
Substantially Equivalent
Date received
2011-07-01
Decision date
2012-04-19
Days to decision
293 days
Clearance type
Traditional
Product code
NQN
Device class
2
Regulation number
864.1860
Medical specialty
Hematology
Advisory committee
Hematology
Location
Tucson, AZ, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Ventana Medical Systems

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
GENASIS HIPATH IHC FAMILY (K140957)Applied Spectral Imaging , Ltd.2015-01-15
VIRTUOSO SYSTEM FOR IHC ER (SP1) WITH BENCHMARK ULTRA STAINER (K140465)Ventana Medical Systems, Inc.2014-03-20
VIRTUOSO SYSTEM FOR IHC ER (SPI) (K130515)Ventana Medical Systems, Inc.2013-11-22
VIRTUOSO SYSTEM FOR IHC HER2 (4B5) (K121516)Ventana Medical Systems, Inc.2013-09-26
VIRTUOSO SYSTEM FOR IHC PR (1E2) BENCHMARK ULTRA STAINER (K122143)Ventana Medical Systems, Inc.2013-09-19
VIRTUOSO SYSTEM FOR IHC PR (IE2) (K111869)Ventana Medical Systems, Inc.2012-03-05
PATHIAM SYSTEM WITH ISCAN FOR P53 AND KI-67 (K092333)Bioimagene, Inc.2010-10-27
SCANSCOPE XT SYSTEM (K073677)Aperio Technologies2008-08-01
VENTANA IMAGE ANALYSIS SYSTEM - PATHWAY HER2 (4B5) (K061613)Tripath Imaging2007-01-10
VENTANA IMAGE ANALYSIS SYSTEM, MODEL VIAS (K062428)Tripath Imaging, Inc.2006-09-29
VENTANA IMAGE ANALYSIS SYSTEM, MODEL KI-67 (K053520)Tripath Imaging, Inc.2006-04-11
VENTANA IMAGE ANALYSIS SYSTEM (K050012)Tripath Imaging, Inc.2005-05-06

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
PATHWAY anti- HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody (P990081/S059)Ventana Medical Systems, Inc.2025-12-15
HER2 Dual ISH DNA Probe Cocktail (P190031/S014)Ventana Medical Systems, Inc.2025-12-15
CINtec PLUS Cytology (P190024/S015)Ventana Medical Systems, Inc.2025-09-04
CINtec PLUS Cytology (P190024/S014)Ventana Medical Systems, Inc.2025-07-31
VENTANA CLDN18 (43-14A) RxDx Assay (P230018/S001)Ventana Medical Systems, Inc.2025-06-20
PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody (P990081/S057)Ventana Medical Systems, Inc.2025-06-20
VENTANA ALK (D5F3) CDX ASSAY (P140025/S025)Ventana Medical Systems, Inc.2025-06-20
VENTANA PD-L1 (SP263) ASSAY (P160046/S020)Ventana Medical Systems, Inc.2025-06-20