Atlas FDA

SCANSCOPE XT SYSTEM

FDA 510(k) clearance K073677 · decided 2008-08-01

Clearance details

K-number
K073677
Device name
SCANSCOPE XT SYSTEM
Applicant
Aperio Technologies
Decision
Substantially Equivalent
Date received
2007-12-28
Decision date
2008-08-01
Days to decision
217 days
Clearance type
Traditional
Product code
NQN
Device class
2
Regulation number
864.1860
Medical specialty
Hematology
Advisory committee
Hematology
Location
Vista, CA, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Aperio Technologies

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 P53 (DO-7) (K111872)Ventana Medical Systems, Inc.2012-04-19
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
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.