ThinPrep Imaging System

Primary DI
15420045501010
Brand
ThinPrep Imaging System
Company
Hologic, Inc.
Model
ThinPrep Imaging System Server
Catalog number
CMP-00816
Device description
Server for use with the ThinPrep® Imaging System to enable review.
Published
2014-09-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MNMREADER, CERVICAL CYTOLOGY SLIDE, AUTOMATED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNMReader, Cervical Cytology Slide, AutomatedUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P020002007

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P020002007THINPREP (R) IMAGING SYSTEMHologic, Inc.2003-06-06MNM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15420045501010PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1542004550101015420045501010

GMDN Terms#

Term, Definition table
TermDefinition
Network serverA device designed to provide electronic data services within a computerized network (e.g., file services like collecting and storing data). It may be a part of a patient monitoring, nurse call, or home alert system.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity20 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Handling Environment Temperature16 Degrees Celsius32 Degrees Celsius
Storage Environment Humidity15 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-28 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)442-9892CustomerSupport@hologic.com

Regulatory Flags#

DUNS number
018925968
Device count
1
DM exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05420045503888SecurMarkSMARK-U-SS1SMARK-U-SS12015-09-04
05420045503895SecurMarkSMARK-U-SS2SMARK-U-SS22015-09-04
05420045503901SecurMarkSMARK-U-SS3SMARK-U-SS32015-09-04
15420045511859Unifi WorkspaceUnifi Workspace V1.02019-08-09
15420045515307Acessa ProVu System710071002023-05-16
15420045515314Acessa ProVu SystemMS-06-0171MS-06-01712023-05-16
15420045515284Acessa ProVu System520052002022-11-08
15420045513983BioZorbF0202F02022021-04-21
15420045513990BioZorbF0203F02032021-04-21
15420045514003BioZorbF0303F03032021-04-21
15420045514010BioZorbF0304F03042021-04-21
15420045514027BioZorbF0221F02212021-04-21
15420045514034BioZorbF0231F02312021-04-21
15420045514041BioZorbF0331F03312021-04-21
15420045514058BioZorbF0404F04042021-04-21
15420045514065BioZorbF0405F04052021-04-21
15420045512634Unifi WorkspaceUnifi Workspace V1.02020-09-21
15420045500020Selenia Dimensions C-View SoftwareC-ViewSW-030522014-09-05
15420045504561ATEC IntroducerAI090920AI0909202016-08-11
15420045504578ATEC IntroducerAI091220AI0912202016-08-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00382904914905BD™ FocalPoint™ Slide Profiler RefurbishedBECTON, DICKINSON AND COMPANYMNM2023-09-08
15420045515062ThinPrep Imaging SystemHologic, Inc.MNM2022-08-24
15420045513716Thinprep Imaging SystemHologic, Inc.MNM2020-06-24
00382904914646BD FocalPoint Slide ProfilerBECTON, DICKINSON AND COMPANYMNM2019-12-03
15420045512511ThinPrep Imaging SystemHologic, Inc.MNM2019-12-03
15420045512535ThinPrep Imaging SystemHologic, Inc.MNM2019-12-03
00382904910907BD FocalPoint™ Slide Profiler RefurbishedBECTON, DICKINSON AND COMPANYMNM2019-06-27
15420045508156ThinPrep Imaging SystemHologic, Inc.MNM2018-10-13
15420045508040ThinPrep Imaging SystemHologic, Inc.MNM2018-05-23
15420045508163Thinprep Imaging SystemHologic, Inc.MNM2017-10-13
00382904901899BD FocalPoint™ GS Review StationBECTON, DICKINSON AND COMPANYMNM2017-09-08
15420045507258ThinPrep Imaging SystemHologic, Inc.MNM2017-02-23
15420045507265ThinPrep Imaging SystemHologic, Inc.MNM2017-02-23
00382904910853BD FocalPointBECTON, DICKINSON AND COMPANYMNM2015-07-22
00382904910860BD FocalPointBECTON, DICKINSON AND COMPANYMNM2015-07-22
00382904910877BD FocalPointBECTON, DICKINSON AND COMPANYMNM2015-07-22
15420045504035ThinPrep Imaging SystemHologic, Inc.MNM2014-09-22
15420045504103ThinPrep Imaging SystemHologic, Inc.MNM2014-09-22
15420045504042ThinPrep Imaging SystemHologic, Inc.MNM2014-09-08
15420045504080ThinPrep Imaging SystemHologic, Inc.MNM2014-09-08
15420045504097ThinPrep Imaging SystemHologic, Inc.MNM2014-09-08
15420045500891ThinPrep Imaging SystemHologic, Inc.MNM2014-09-02
15420045500907ThinPrep Imaging SystemHologic, Inc.MNM2014-09-02
15420045500914ThinPrep Imaging SystemHologic, Inc.MNM2014-09-02
15420045500921ThinPrep Imaging SystemHologic, Inc.MNM2014-09-02
15420045500938ThinPrep Imaging SystemHologic, Inc.MNM2014-09-02
15420045500945ThinPrep Imaging SystemHologic, Inc.MNM2014-09-02
15420045500976ThinPrep Imaging SystemHologic, Inc.MNM2014-09-02
15420045500983ThinPrep Imaging SystemHologic, Inc.MNM2014-09-02
15420045500990ThinPrep Imaging SystemHologic, Inc.MNM2014-09-02