The BladeView is a full featured Radiographic Flat-Panel Digital Imaging System. It Is intended to replace conventional film screen systems. The BiadeView allows a qualified operator to perform digital radiographic examinations of various anatomic regions on both adult and pediatric patients. Anatomic regions of interest for diagnostic radiographic exposure include: skull, spinal column, chest, shoulder girdle, abdomen, pelvic girdle and extremittee. The BladeView enables a qualified operator to acquire, process, and display images. The BladeView system enables the qualified operator to store, hardcopy images with a laser printer or send images over a network. This device is not intended for mammographic, fluoroscopic and or anglographic applications.

Device Description

The BladeView is a device intended to visualize anatomical structures by converting a pattern of X-ray into a visible image. The main configuration includes a portable X-ray detector, generator, workstation and various other allied parts and components necessary for radiographic studies. It is also configurable to be used in an existing conventional radiographic room (Film or CR) and only the Flat panel and workstation would be needed. The system has medications ranging from but not limited to cranial, skeletal, thoracic and lung exposures as well as examination of the extremities.

AI/ML Overview

The provided 510(k) summary for the "BladeView" device does not describe specific acceptance criteria and a detailed study proving the device meets those criteria in the way typically found for AI/ML-driven devices with quantitative performance metrics.

Instead, this submission focuses on demonstrating substantial equivalence to predicate devices (CPI RAD VISION K083224 and Pausch HDR Vision K081073) by comparing:

Intended Use: Showing the BladeView's intended use is substantially similar to or a subset of the predicate devices.
Technological Characteristics: Highlighting that the core technology (X-ray received by Flat Panel Detector, digital image conversion, processing, storage, and distribution) is the same. Differences noted are primarily about the BladeView not including fluoroscopy capabilities present in one predicate, which is justified as not affecting safety or effectiveness for its intended radiographic use.

There is no mention of a performance study with detailed acceptance criteria, sample sizes, ground truth establishment, expert adjudication, or comparative effectiveness studies (MRMC) to quantify the device's diagnostic accuracy or improvement over human performance. This type of detailed performance evaluation is more common for novel diagnostic algorithms or AI/ML-driven systems where performance is not inherently similar to existing devices due to a different mechanism of action or analytical principle.

Therefore, many sections of your request cannot be fulfilled from the provided document.

However, I can extract the information that is present:

1. A table of acceptance criteria and the reported device performance:

This document does not specify quantitative acceptance criteria or reported device performance in terms of diagnostic accuracy (e.g., sensitivity, specificity, AUC). The "performance" assessment is qualitative, relying on comparison to predicate devices, asserting that the BladeView operates on the same technological principles for its intended use.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

Not applicable. No performance study with a test set is described.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

Not applicable. No performance study with ground truth establishment is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. No performance study with adjudication is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. No MRMC study is described. The device is a "Flat Panel Digital Imaging System" and is not described as having "AI assistance" in the sense of an algorithm interpreting images for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. The BladeView is a digital X-ray imaging system, not presented as an "algorithm only" device. Its function is to acquire, process, and display images for a qualified operator.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not applicable. No performance study is described that would require ground truth.

8. The sample size for the training set:

Not applicable. The document describes a medical device (digital X-ray imager), not an AI/ML algorithm that undergoes a "training set" in the context of machine learning.

9. How the ground truth for the training set was established:

Not applicable. See #8.

Summary of Device Equivalence (as presented in the document):

The submission argues for substantial equivalence based on the following:

Intended Use: The BladeView is a full-featured Radiographic Flat-Panel Digital Imaging System intended to replace conventional film screen systems. It allows qualified operators to perform digital radiographic examinations of various anatomical regions (skull, spinal column, chest, shoulder girdle, abdomen, pelvic girdle, extremities) on adult and pediatric patients. It enables image acquisition, processing, display, storage, hardcopy printing, or network transmission. It is explicitly "not intended for mammographic, fluoroscopic and or angiographic applications." This intended use is compared to the predicate devices and differences are explained as either minor phrasing adjustments, or a subset of practices (e.g., BladeView not doing fluoroscopy) which does not affect safety or effectiveness for its specific intended use.
Technological Characteristics: Both the BladeView and the predicate devices (CPI RAD VISION K083224 and Pausch HDR Vision K081073) use X-rays received by a Flat Panel Detector to create diagnostic images. The detector converts images into a digital format for viewing, processing, local storage, archiving, printing, or sending to DICOM devices. The key difference noted with the Pausch HDR Vision is that BladeView does not perform fluoroscopy and does not use a fluoroscopy-capable Flat Panel Detector, being designed solely for radiographic images. This difference is argued to not affect safety and effectiveness for BladeView's intended purpose.

In conclusion, this 510(k) summary for the "BladeView" device demonstrates substantial equivalence through a direct comparison of intended use and technological characteristics with predicate devices, rather than through a detailed clinical performance study with quantitative acceptance criteria and metrics.

Summary

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K101042

644 North Lake Way, Palm Beach, FL 33480

OCT 2 9 2010

810(k) Summary

Note: This is the "510(k) Summary" as required by section 807.92(c)

Accogent, LLC 510(k) Pre-market Notification; BladeView

Date: May 12", 2010 Submitter's Name: Accogent, LLC Submitter's Address: 644 North Lake Way Palm Beach, FL Submitter's Contact: Tristan Tice, Managing Member Submitter's Telephone Number: (917) 513-7632 Submitter's Fax Number: (732) 747-6073

Establishment Registration Number: 3007230269

Device Name and Classification

Trade Name:	BladeView	CFR Section:	21 CFR § 892.1650
Classification Panel:	Radiology	Device Class:	Class II
Classification Name:	Solid State x-ray Imager(Flat Panel/Digital Imager)	Device Code:	MQB
Common Name:	Radiographic Digital Flat Panel Detector System

Performance Standard: 21 CFR Subchapter J, Federal Diagnostic X-ray Equipment Standard

Predicate Device Claiming	CPI RAD VISION
Substantial Equivalence to:	510(k) Control Number: K083224
Predicate Device Claiming	HDR Vision
Substantial Equivalence to:	510(k) Control Number: K081073

Reason For Submission New device

Description of this Device:

he BladeView is intended to be used as a universal diagnostic imaging system for radiographic studies.

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ACCENT

The system has medications ranging from but not limited to cranial, skeletal, thoracic and lung exposures as well as examination of the extremities.

Summary of Intended Uses:

The BladeView is a full featured Radiographic Flat-Panel Digital Imaging System. It Is Intended to replace conventional film screen systems.

The BladeView allows a qualified operator to perform digital radiographic examinations of various anatomic regions annos edult and pediatin adjudinations of interest for diagnostic radio and exposure include: skull, spinal column, chest, shoulder girdle, abdomen, pelvic girdle and extremittes.

The BladeView enables a qualified operator to acquire, process, and display images. The BladeView system enables the qualified operator to store, hardcopy images with a laser printer or send images over a network.

This device is not intended for mammographic, fluoroscopic and or anglographic applications.

Analyeis of the Indications For Use for the Subject Device and Predicate Device(s): Pursuant to §807.92(a)(5), this summary contains the following information as to why differences are not critical to the intented therapeutic, diagnostic, or surgical use of the device. In addition, this summary also contains an explanation why the differences do not affect the safety and effectiveness of the device.

A comparison of the subject device and the CPI RAD VISION (K093224) is as follows:

CPI RADVISION(K083224)PREDICATEDEVICE	BladeViewSUBJECT DEVICE	EXPLANATION WHYDIFFERENCES ARE NOTCRITICAL TO USE OF THEDEVICE	WHY DIFFERENCES DO NOTAFFECT THE SAFETY ANDEFFECTIVENESS OF THEDEVICE
	CPI RADVISION(K083224)PREDICATEDEVICE	BLADEVIEWSUBJECT DEVICE	EXPLANATION WHYDIFFERENCES ARE NOTCRITICAL TO USE OF THEDEVICE	WHY DIFFERENCES DO NOTAFFECT THE SAFETY ANDEFFECTIVENESS OF THEDEVICE
A1	The CPI RADVISION is a fullfeaturedRadiographicFlat PanelDigital ImagingSystem for X-ray Generatorand Acquisitionof digitalradiography.	The BladeViewis a full featuredRadiographicFlat-PanelDigital ImagingSystem.	The difference is notcritical to the intendeddiagnostic use of thedevice. The difference isdone to clear up anyconfusion or conflicts ofinterpretation.	The difference will notaffect the safety andeffectiveness of the devicewhen used as labeled. Theadditional text is seen asbeing restatement ofsomething that is implicitwith the device as it isdescribed in the DeviceDescription Section.
A2	The CPI RAD.VISION isconfigurable toany highresolution (3K x3K) Solid StateX-Ray Imager(SSXI)presently in themarket.		The difference is notcritical to the Intendeddiagnostic use of thedevice. The difference isdone because submitterdoes not wish to claimconfigurability as theintended diagnostic usewill focused on its ownDigital Flat Panel, and notthe flat panel of ourcompetitors.	The difference will notaffect the safety andeffectiveness of the devicewhen used as labeled.This is exact claim that isdifficult to support,however the Safety andeffectiveness of the device(as well as its intendeduse) is not affected as theapplicant's system will stillultimately have the sameintended use (Thegenerating of digitalradiographic images of thehuman anatomy).
A3	it is intended toreplaceconventionalfilm screensystems.	It is intended toreplaceconventionalfilm screensystems.	There is no difference inthe intended diagnosticuse of the device.	There is no differencebetween both IFU's.Therefore there will be noaffect in the safety andeffectiveness of the devicewhen used as labeled.
	CPI RADVISION(K083224)PREDICATEDEVICE	BLADEVIEWSUBJECT DEVICE	EXPLANATION WHYDIFFERENCES ARE NOTCRITICAL TO USE OF THEDEVICE	WHY DIFFERENCES DO NOTAFFECT THE SAFETY ANDEFFECTIVENESS OF THEDEVICE
B1	The CPI RADVISION allowsa qualifiedoperator toperform digitalradiographicexaminations ofvariousanatomicregions on bothadult andpediatricpatients.	The BladeViewallows aqualifiedoperator toperform digitalradiographicexaminations ofvariousanatomicregions on bothadult andpediatricpatients.	There is no difference inthe Intended diagnosticuse of the device.	There is no differencebetween both IFU's.Therefore there will be noaffect in the safety andeffectiveness of the devicewhen used as labeled.
B2	Anatomicregions ofInterest fordiagnosticradiographicexposureinclude: skull,spinal column,chest, shouldergirdle,abdomen,pelvic girdleand extremities.	Anatomicregions ofInterest fordiagnosticradiographicexposureinclude: skull,spinal column,chest, shouldergirdle,abdomen,pelvic girdleand extremities.	There is no difference inthe Intended diagnosticuse of the device.	There is no differencebetween both IFU's.Therefore there will be noaffect in the safety andeffectiveness of the devicewhen used as labeled.
	CPI RADVISION(K083224)PREDICATEDEVICE	BLADEVIEWSUBJECT DEVICE	EXPLANATION WHYDIFFERENCES ARE NOTCRITICAL TO USE OF THEDEVICE	WHY DIFFERENCES DO NOTAFFECT THE SAFETY ANDEFFECTIVENESS OF THEDEVICE
C1	The CPI RADVISION enablesa qualifiedoperator toacquire,process, anddisplay Imageswith for thebenefit ofobtaining anoptimaldiagnosticproduct.	The BladeViewenables aqualifiedoperator toacquire,process, anddisplay images.	The first part is notdifferent, however thesecond part is. Thedifference is not critical tothe intended diagnosticuse of the device. Thedifference is done becausethe predicate device'sclaim is difficult to supportwith quantitative data.	The difference will notaffect the safety andeffectiveness of the devicewhen used as labeled.Both systems use thesame detector from thesame manufacturer. Thisdetector provides anoutput image that isviewable already useablein its native format. Thisadditional text that is notbrought forward (excludingthe "optimal" claimcomponent) is seen asbeing restatement ofsomething that is implicitwith the device as it is asystem being promulgatedto obtain diagnosticimages..
C2	The CPI RADVISION systemenables thequalifiedoperator tostore, hardcopyimages with alaser printer orsend imagesover a network.	The BladeViewsystem enablesthe qualifiedoperator tostore, hardcopyimages with alaser printer orsend Imagesover a network.	There is no difference inthe intended diagnosticuse of the device.	There is no differencebetween both IFU's.Therefore there will be noaffect in the safety andeffectiveness of the devicewhen used as labeled.
C3	This device isnot intended formammographic,fluoroscopicand orangiographicapplications.	This device isnot intended formammographic,fluoroscopicand orangiographicapplications.	There is no difference inthe intended diagnosticuse of the device.	There is no differencebetween both IFU's.Therefore there will be noaffect in the safety andeffectiveness of the devicewhen used as labeled.
	CPI RADVISION(K083224)PREDICATEDEVICE	BLADEVIEWSUBJECT DEVICE	EXPLANATION WHYDIFFERENCES ARE NOTCRITICAL TO USE OF THEDEVICE	WHY DIFFERENCES DO NOTAFFECT THE SAFETY ANDEFFECTIVENESS OF THEDEVICE
C4	The CPI RADVISION will notinclude the X-Ray systemitself.		The difference is notcritical to the intendeddiagnostic use of thedevice. Specifically, thedifference is done to clearup any confusion orconflicts of interpretation.	There is no difference thatwill affect the safety andeffectiveness of the devicewhen used as labeled.
D1	Device is forPrescriptiononly	Device is forPrescriptiononly	There is no difference inthe intended diagnosticuse of the device.	There is no differencebetween both IFU's.Therefore there will be noaffect in the safety andeffectiveness of the devicewhen used as labeled.

SECTION H

510(K) Summary

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KI01042
PAGE 4 OF 10

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•

SECTION H

510(K) Summary

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. .

K101042
PAGE 6 OF 10

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.' ··

ﺎﺕ

A comparison of the subject device and the Pausch HDR Vision (K081073) is as follows:

	HDR Vision(K081073)PredicateDevice	BladeViewSubject Device	Explanation WhyDifferences are not Criticalto Use of the Device	Why Differences do notAffect the Safety andEffectiveness of the Device
A1	The HDR Vision isIntended to be usedas a universaldiagnostic imagingsystem forradiographic andfluoroscopic studies.	The BladeViewis a full featuredRadiographicFlat-PanelDigital ImagingSystem.	Applicant's system isintended for Radiographicexaminations	The difference is notcritical to the intendeddiagnostic use of thedevice becausefluoroscopic examinationsare not to be done with it.
A2	Using a digital flatdetector, it canperform a range ofapplicationsIncluding generalRIF, angiographyand pediatricexaminations.	The BladeViewis a full featuredRadiographicFlat-PanelDigital ImagingSystem.	Applicant's system isintended for Radiographicexaminations	The difference is notcritical to the intendeddiagnostic use of thedevice becausefluoroscopic examinationsare not to be done with it.
A3	The HDR Vision is adevice intended tovisualize anatomicalstructures byconverting a patternof X-ray into avisible image.	It is intended toreplaceconventionalfilm screensystems.	Both passages aresubstantially similar, thedifference is that thepredicate device is explicitand the submission isImplicit	There is no difference inthe Intended diagnosticuse of the device.
B1	The system hasmedical applicationsranging from but notlimited togastrointestinalexaminations,cranial, skeletal,thoracic and lungexposures as wellas examination ofthe urogenital tract.	The BladeViewallows aqualifiedoperator toperform digitalradiographicexaminations ofvariousanatomicregions on bothadult andpediatricpatients.	Only conventionalradiographic exposuresapply. It is for these usesthat device similaritybetween the two devicesexist. Howevergastrointestinalexamination andexaminations of theurogenital tract are notfound in the submissionand therefore are not aclaimed indication of use.	There is a difference in theintended diagnostic use ofthe device however,applicant is not including inits indications for use anyincompatible procedures.To reiterate the differencesare not critical to theapplicant's device as it'sIntended diagnostic use isthat of a Radiographic Flat-Panel Digital ImagingSystem.
	HDR Vision(K081073)PredicateDevice	BladeViewSubject Device	Explanation WhyDifferences are not Criticalto Use of the Device	Why Differences do notAffect the Safety andEffectiveness of the Device
B2	The units may alsobe used inlymphography,endoscopy,myelography,venography,pediatrics,arthrography,Interventionalradiology, digitalangiography anddigital subtractionangiography (DSA).	Anatomicregions ofInterest fordiagnosticradiographicexposureInclude: skull,spinal column,chest, shouldergirdle,abdomen,pelvic girdleand extremities.	Only the conventionalradiographic proceduresapplicable to thesubmission are broughtforward. The otherprocedures are notclaimed by the submittertherefore they are notincluded in submission'sIFU.	The difference is notcritical to the intendeddiagnostic use of thedevice because onlyconventional radiographyare to be done with it. Anyother uses would claimedneed to be separatelybroken out and explicitlyclaimed. These additionalprocedures are not beingdone for the applicant'ssubmitted device.
C1	HDR Visionmay be used foroutpatient andemergencytreatment, aswell as formobile transport(wheelchair andbed)examinations.	The BladeViewenables aqualifiedoperator toacquire,process, anddisplay images.	Applicant's system isIntended for Radiographicexaminations. While theseare seen as being mostlyconventional radiographicexposures they are notincluded in the applicant'sIFU as it wanted to stayclose to the IFU put for byCPI in its submission(K083224)	The difference is notcritical to the intendeddiagnostic use of thedevice. Submission hasnot brought forward theseitems (bed & wheelchair)as they are commonplacein the modern US hospitalenvironment all othersubmissions for digitalradiographic devices donot feel the need toenumerate on these typesof examinations.
C2		The BladeViewsystem enablesthe qualifiedoperator tostore, hardcopyimages with alaser printer orsend imagesover a network.	Applicant's system isIntended for Radiographicexaminations. Thesefunctions are almostimplicit with any moderndigital radiographicsystem. This is included inthe applicant's IFU as itwanted to stay close to theIFU put for by CPI in itssubmission (K083224)	There is no difference inthe Intended diagnosticuse of the device as thesefeatures are inferred in theHDR Vision 510(k)summary in the Summaryof Intended Uses Sectionwhere it states "Thesystem is used for imageacquisition, image display,and thetransmission/output ofimages to externaldevices."
	HDR Vision(K081073)PredicateDevice	BladeViewSubject Device	Explanation Why.Differences are not Criticalto Use of the Device	Why Differences do notAffect the Safety andEffectiveness of the Device
C3		This device isnot intended formammographic,fluoroscopicand orangiographicapplications.	Applicant's system isIntended for Radiographicexaminations. Thesefunctions are excluded bythe applicant as. This isIncluded in the applicant'sIFU as it wanted to stayclose to the IFU put for byCPI in its submission(K083224)	The difference is not critical to theintended diagnostic use of thedevice because only conventionalradiography are to be done with it.Any other uses would claimedneed to be separately broken outand explicitly claimed. Theseadditional procedures(Fluoroscopy and anglographicapplications) are not being donefor the applicant's submitteddevice (Therefore they are notcritical to the intended use of thedevice).
D1	Device is forPrescriptiononly	Device is forPrescriptiononly	Both passages aresubstantially similar.	There is no difference inthe Intended diagnosticuse of the device withrespect to this issue

Section H

510(K) Summary .

K101042
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SECTION H

510(K) Summary

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Summary of Technological Characteristics for the Subject Device and Predicate Device(s):

Pursuant to 5807.92(a)(6), this 510(k) summary contains the summary of the technological characteristics of the subject device compared to the predicate device(s). Where the device eparty several as the secall characteristics (l.e., design, material, chemical composition, energy source) as the predicate device, there is a summary of the technological characteristics of the new device is nomparison to those of the predicate device. Where the subject device has different technological characteristics from the predicate device, a summary is provided of how the technological characteristics of subject device compare to the predicate device.

Summary of Technological Characteristics for the Subject Device and the CPI RAD VISION (K083224) Predicate Device:

Applicant submission of the required technical characteristics analysis is done using solely the information provided to redicate device's (CPI's K083224) 510(K) Summary. This summary is as follows:

The technological characteristics are the same in the proposed and predicate devices. Both the predicate and new devices use x-rays received by Flat Panel Detector (acquisition) to create dagnostic images The detector converts the Imeges into a digital form that can be viewed in a native format or state. Supplementary to the process it can be adjusted in necessary (processing), then stored locally (storage), sent to an archive, printed or sent to supported DICOM devices (distribution of Images).

SECTION H

510(K) Summary

101047 9 OF 10

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Summary of Technological Characteristics for the Subject Device and the Pausch VISION HDR (K081073) Predicate Device:

The following technological characteristics are the same in the proposed and prodicate devices with respect to the following:

Both the predicate and new devices use x-rays received by Flat Panel Detector (acquisition)to create diagnostic images. The detector converts the images into a digital form that can be viewed in a native format or state. Supplementary to the process it can be adjusted if necessary (processing), then stored locally (storage), sent to an archive, printed or sent to supported DICOM devices (distribution of images).

The following technological characteristics are different in the proposed and predicate devices with respect to the following:

The submitted device does not perform fiuoroscopy, nor does it use a Flat Panel Detector that is capable of performing Fluoroscopy. The predicate device has the technology to perform fiuoroscopy, and it contains a Flat Panel Detector capable of doing Fluoroscopy. The submitted device is designed only to acquire and process radiographic images. The predicate device is designed to acquire and process radiographic images, fluoroscopic studies and numerous other procedures that submitted device is not qualified or otherwise intended to do.

End of 510(k) Summary

610(K) SUMMARY

K101042
PAGE 10 OF 10

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Accogent LLC % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313

Re: K101042

Trade/Device Name: Blade View Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR and MQB Dated: September 24, 2010 Received: September 28, 2010

AUG 23 2013

Dear Mr. Job:

This letter corrects our substantially equivalent letter of October 29, 2010.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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K10104

INDICATIONS FOR USE STATEMENT

OCT 2 9 2010

Indications for Use

510(k) Number: K101042

Device Name: BladeView

Indications For Use:

The BladeView is a full featured Radiographic Flat-Panel Digital Imaging System. It Is intended to replace conventional film screen systems.

The BiadeView allows a qualified operator to perform digital radiographic examinations of various anatomic regions on both adult and pediatric patients. Anatomic regions of interest for diagnostic radiographic exposure include: skull, spinal column, chest, shoulder girdle, abdomen, pelvic girdle and extremittee.

This device is not intended for mammographic, fluoroscopic and or anglographic applications.

AND/OR

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Signature

10/29/10

Page 1 of 1

SECTION G

INDICATIONS FOR USE STATEMENT

Page 1 of 1

Regulation Number and Section

§ 892.1680 Stationary x-ray system.

(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.