Who is the manufacturer of BLADEVIEW?

Accogent, LLC filed the 510(k) submission for BLADEVIEW (K101042).

What is the FDA product code for BLADEVIEW?

KPR. It is classified under 21 CFR 892.1680 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for BLADEVIEW?

510(k) clearance (submission type: Traditional).

What are the predicate devices for BLADEVIEW?

CPI RAD VISION (K083224); HDR Vision (K081073).

Who can help prepare an FDA 510(k) submission like BLADEVIEW?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

BLADEVIEW

K101042 · Accogent, LLC · KPR · Oct 29, 2010 · Radiology

Device Facts

Record ID	K101042
Device Name	BLADEVIEW
Applicant	Accogent, LLC
Product Code	KPR · Radiology
Decision Date	Oct 29, 2010
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1680
Device Class	Class 2
Attributes	Pediatric, 3rd-Party Reviewed

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. 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 Story

BladeView is a radiographic digital flat-panel imaging system designed to replace conventional film-screen systems. It captures X-ray patterns using a portable flat-panel detector, converting them into digital images. The system includes a generator, workstation, and detector; it can be integrated into existing radiographic rooms. Operated by qualified personnel, the system acquires, processes, and displays images for diagnostic review. Images can be stored locally, printed via laser printer, or transmitted over a network. By providing digital output, the device facilitates efficient diagnostic imaging of skeletal and thoracic anatomy, aiding clinicians in patient assessment and diagnosis.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Radiographic digital flat-panel detector system. Components include X-ray generator, flat-panel detector, and workstation. Operates by converting X-ray patterns to digital images. Supports DICOM connectivity for image distribution, storage, and printing. Complies with 21 CFR Subchapter J. System is non-fluoroscopic.

Indications for Use

Indicated for adult and pediatric patients requiring digital radiographic examinations of the skull, spinal column, chest, shoulder girdle, abdomen, pelvic girdle, and extremities. Contraindicated for mammographic, fluoroscopic, and angiographic applications.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

CPI RAD VISION (K083224)
HDR Vision (K081073)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the word "ACCENT" in a stylized font. The letters are bold and black, and the two "C"s are overlapping. The letters are closely spaced together, creating a compact and unified appearance. ### 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. P. 1 of 10 {1}------------------------------------------------ # ACCENT 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. #### 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 RAD VISION (K083224) PREDICATE DEVICE | BladeView SUBJECT DEVICE | EXPLANATION WHY DIFFERENCES ARE NOT CRITICAL TO USE OF THE DEVICE | WHY DIFFERENCES DO NOT AFFECT THE SAFETY AND EFFECTIVENESS OF THE DEVICE | | |-------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | CPI RAD VISION (K083224) PREDICATE DEVICE | BLADEVIEW SUBJECT DEVICE | EXPLANATION WHY DIFFERENCES ARE NOT CRITICAL TO USE OF THE DEVICE | WHY DIFFERENCES DO NOT AFFECT THE SAFETY AND EFFECTIVENESS OF THE DEVICE | | A1 | The CPI RAD VISION is a full featured Radiographic Flat Panel Digital Imaging System for X- ray Generator and Acquisition of digital radiography. | The BladeView is a full featured Radiographic Flat-Panel Digital Imaging System. | The difference is not critical to the intended diagnostic use of the device. The difference is done to clear up any confusion or conflicts of interpretation. | The difference will not affect the safety and effectiveness of the device when used as labeled. The additional text is seen as being restatement of something that is implicit with the device as it is described in the Device Description Section. | | A2 | The CPI RAD. VISION is configurable to any high resolution (3K x 3K) Solid State X-Ray Imager (SSXI) presently in the market. | | The difference is not critical to the Intended diagnostic use of the device. The difference is done because submitter does not wish to claim configurability as the intended diagnostic use will focused on its own Digital Flat Panel, and not the flat panel of our competitors. | The difference will not affect the safety and effectiveness of the device when used as labeled. This is exact claim that is difficult to support, however the Safety and effectiveness of the device (as well as its intended use) is not affected as the applicant's system will still ultimately have the same intended use (The generating of digital radiographic images of the human anatomy). | | A3 | it is intended to replace conventional film screen systems. | It is intended to replace conventional film screen systems. | There is no difference in the intended diagnostic use of the device. | There is no difference between both IFU's. Therefore there will be no affect in the safety and effectiveness of the device when used as labeled. | | | CPI RAD VISION (K083224) PREDICATE DEVICE | BLADEVIEW SUBJECT DEVICE | EXPLANATION WHY DIFFERENCES ARE NOT CRITICAL TO USE OF THE DEVICE | WHY DIFFERENCES DO NOT AFFECT THE SAFETY AND EFFECTIVENESS OF THE DEVICE | | B1 | The CPI RAD VISION allows a qualified operator to perform digital radiographic examinations of various anatomic regions on both adult and pediatric patients. | The BladeView allows a qualified operator to perform digital radiographic examinations of various anatomic regions on both adult and pediatric patients. | There is no difference in the Intended diagnostic use of the device. | There is no difference between both IFU's. Therefore there will be no affect in the safety and effectiveness of the device when used as labeled. | | B2 | Anatomic regions of Interest for diagnostic radiographic exposure include: skull, spinal column, chest, shoulder girdle, abdomen, pelvic girdle and extremities. | Anatomic regions of Interest for diagnostic radiographic exposure include: skull, spinal column, chest, shoulder girdle, abdomen, pelvic girdle and extremities. | There is no difference in the Intended diagnostic use of the device. | There is no difference between both IFU's. Therefore there will be no affect in the safety and effectiveness of the device when used as labeled. | | | CPI RAD VISION (K083224) PREDICATE DEVICE | BLADEVIEW SUBJECT DEVICE | EXPLANATION WHY DIFFERENCES ARE NOT CRITICAL TO USE OF THE DEVICE | WHY DIFFERENCES DO NOT AFFECT THE SAFETY AND EFFECTIVENESS OF THE DEVICE | | C1 | The CPI RAD VISION enables a qualified operator to acquire, process, and display Images with for the benefit of obtaining an optimal diagnostic product. | The BladeView enables a qualified operator to acquire, process, and display images. | The first part is not different, however the second part is. The difference is not critical to the intended diagnostic use of the device. The difference is done because the predicate device's claim is difficult to support with quantitative data. | The difference will not affect the safety and effectiveness of the device when used as labeled. Both systems use the same detector from the same manufacturer. This detector provides an output image that is viewable already useable in its native format. This additional text that is not brought forward (excluding the "optimal" claim component) is seen as being restatement of something that is implicit with the device as it is a system being promulgated to obtain diagnostic images.. | | C2 | The CPI RAD VISION system enables the qualified operator to store, hardcopy images with a laser printer or send images over a network. | The BladeView system enables the qualified operator to store, hardcopy images with a laser printer or send Images over a network. | There is no difference in the intended diagnostic use of the device. | There is no difference between both IFU's. Therefore there will be no affect in the safety and effectiveness of the device when used as labeled. | | C3 | This device is not intended for mammographic, fluoroscopic and or angiographic applications. | This device is not intended for mammographic, fluoroscopic and or angiographic applications. | There is no difference in the intended diagnostic use of the device. | There is no difference between both IFU's. Therefore there will be no affect in the safety and effectiveness of the device when used as labeled. | | | CPI RAD VISION (K083224) PREDICATE DEVICE | BLADEVIEW SUBJECT DEVICE | EXPLANATION WHY DIFFERENCES ARE NOT CRITICAL TO USE OF THE DEVICE | WHY DIFFERENCES DO NOT AFFECT THE SAFETY AND EFFECTIVENESS OF THE DEVICE | | C4 | The CPI RAD VISION will not include the X- Ray system itself. | | The difference is not critical to the intended diagnostic use of the device. Specifically, the difference is done to clear up any confusion or conflicts of interpretation. | There is no difference that will affect the safety and effectiveness of the device when used as labeled. | | D1 | Device is for Prescription only | Device is for Prescription only | There is no difference in the intended diagnostic use of the device. | There is no difference between both IFU's. Therefore there will be no affect in the safety and effectiveness of the device when used as labeled. | SECTION H 510(K) Summary {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the word "ACCENT" in a stylized font. The two "C" letters are designed as interlocking circles. The letters are bold and black, contrasting with the white background. K // /////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////// {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the word "ACCENT" in a stylized font. The two "C" letters are designed as overlapping circles. The "E" is designed with a horizontal line through the middle. / , . . KI01042 PAGE 4 OF 10 {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the word "ACCENT" in a stylized font. The two "C" letters are designed as overlapping circles. The letters are bold and black, contrasting with the white background. • SECTION H 510(K) Summary . . {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the word "ACCOSENT" in a stylized font. The two "C" letters in the middle are designed as interlocking circles. The letters are all in black and the background is white. . . K101042 PAGE 6 OF 10 {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the word "ACCENT" in a stylized font. The two "C" letters are designed as interlocking circles. The word is written in a bold, sans-serif font, and the letters are closely spaced together. .' ·· ﺎﺕ F A comparison of the subject device and the Pausch HDR Vision (K081073) is as follows: | | HDR Vision (K081073) Predicate Device | BladeView Subject Device | Explanation Why Differences are not Critical to Use of the Device | Why Differences do not Affect the Safety and Effectiveness of the Device | |----|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | A1 | The HDR Vision is Intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. | The BladeView is a full featured Radiographic Flat-Panel Digital Imaging System. | Applicant's system is intended for Radiographic examinations | The difference is not critical to the intended diagnostic use of the device because fluoroscopic examinations are not to be done with it. | | A2 | Using a digital flat detector, it can perform a range of applications Including general RIF, angiography and pediatric examinations. | The BladeView is a full featured Radiographic Flat-Panel Digital Imaging System. | Applicant's system is intended for Radiographic examinations | The difference is not critical to the intended diagnostic use of the device because fluoroscopic examinations are not to be done with it. | | A3 | The HDR Vision is a device intended to visualize anatomical structures by converting a pattern of X-ray into a visible image. | It is intended to replace conventional film screen systems. | Both passages are substantially similar, the difference is that the predicate device is explicit and the submission is Implicit | There is no difference in the Intended diagnostic use of the device. | | B1 | The system has medical applications ranging from but not limited to gastrointestinal examinations, cranial, skeletal, thoracic and lung exposures as well as examination of the urogenital tract. | The BladeView allows a qualified operator to perform digital radiographic examinations of various anatomic regions on both adult and pediatric patients. | Only conventional radiographic exposures apply. It is for these uses that device similarity between the two devices exist. However gastrointestinal examination and examinations of the urogenital tract are not found in the submission and therefore are not a claimed indication of use. | There is a difference in the intended diagnostic use of the device however, applicant is not including in its indications for use any incompatible procedures. To reiterate the differences are not critical to the applicant's device as it's Intended diagnostic use is that of a Radiographic Flat- Panel Digital Imaging System. | | | HDR Vision (K081073) Predicate Device | BladeView Subject Device | Explanation Why Differences are not Critical to Use of the Device | Why Differences do not Affect the Safety and Effectiveness of the Device | | B2 | The units may also be used in lymphography, endoscopy, myelography, venography, pediatrics, arthrography, Interventional radiology, digital angiography and digital subtraction angiography (DSA). | Anatomic regions of Interest for diagnostic radiographic exposure Include: skull, spinal column, chest, shoulder girdle, abdomen, pelvic girdle and extremities. | Only the conventional radiographic procedures applicable to the submission are brought forward. The other procedures are not claimed by the submitter therefore they are not included in submission's IFU. | The difference is not critical to the intended diagnostic use of the device because only conventional radiography are to be done with it. Any other uses would claimed need to be separately broken out and explicitly claimed. These additional procedures are not being done for the applicant's submitted device. | | C1 | HDR Vision may be used for outpatient and emergency treatment, as well as for mobile transport (wheelchair and bed) examinations. | The BladeView enables a qualified operator to acquire, process, and display images. | Applicant's system is Intended for Radiographic examinations. While these are seen as being mostly conventional radiographic exposures they are not included in the applicant's IFU as it wanted to stay close to the IFU put for by CPI in its submission (K083224) | The difference is not critical to the intended diagnostic use of the device. Submission has not brought forward these items (bed & wheelchair) as they are commonplace in the modern US hospital environment all other submissions for digital radiographic devices do not feel the need to enumerate on these types of examinations. | | C2 | | The BladeView system enables the qualified operator to store, hardcopy images with a laser printer or send images over a network. | Applicant's system is Intended for Radiographic examinations. These functions are almost implicit with any modern digital radiographic system. This is included in the applicant's IFU as it wanted to stay close to the IFU put for by CPI in its submission (K083224) | There is no difference in the Intended diagnostic use of the device as these features are inferred in the HDR Vision 510(k) summary in the Summary of Intended Uses Section where it states "The system is used for image acquisition, image display, and the transmission/output of images to external devices." | | | HDR Vision (K081073) Predicate Device | BladeView Subject Device | Explanation Why. Differences are not Critical to Use of the Device | Why Differences do not Affect the Safety and Effectiveness of the Device | | C3 | | This device is not intended for mammographic, fluoroscopic and or angiographic applications. | Applicant's system is Intended for Radiographic examinations. These functions are excluded by the applicant as. This is Included in the applicant's IFU as it wanted to stay close to the IFU put for by CPI in its submission (K083224) | The difference is not critical to the intended diagnostic use of the device because only conventional radiography are to be done with it. Any other uses would claimed need to be separately broken out and explicitly claimed. These additional procedures (Fluoroscopy and anglographic applications) are not being done for the applicant's submitted device (Therefore they are not critical to the intended use of the device). | | D1 | Device is for Prescription only | Device is for Prescription only | Both passages are substantially similar. | There is no difference in the Intended diagnostic use of the device with respect to this issue | Section H - 510(K) Summary . K101042 PAGE 7 OF 10 {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the word "ACCCCENT" in a stylized, bold font. The letters are closely spaced, with some overlapping, creating a unique visual effect. The font appears to be sans-serif, and the overall design is simple yet eye-catching. SECTION H . 510(K) Summary {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the word "ACCENT" in a stylized font. The letters are bold and black, with the two "C"s overlapping each other in the center of the word. The font is sans-serif and appears to be custom-designed. #### 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 {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the word "ACCENT" in a stylized font. The two "C" letters are designed as interlocking circles. The letters are bold and black, contrasting with the white background. 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 {10}------------------------------------------------ Image /page/10/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle. The eagle is facing to the right and has its wings spread. #### 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 {11}------------------------------------------------ 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 {12}------------------------------------------------ ## 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. 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. 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

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