(198 days)
Not Found
No
The summary describes a standard digital radiographic imaging system with image processing capabilities, but there is no mention of AI, ML, or related terms.
No
The device is described as a diagnostic imaging system for radiographic examinations, not for therapeutic interventions.
Yes
The device is intended to perform digital radiographic examinations of various anatomic regions for diagnostic exposure, enabling a qualified operator to acquire, process, and display images for diagnosis.
No
The device description explicitly states that the main configuration includes hardware components such as a portable X-ray detector, generator, and workstation, in addition to software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or treatment.
- The BladeView is a radiographic imaging system. It uses X-rays to create images of internal anatomical structures within the patient's body. It does not analyze samples taken from the body.
The description clearly states its purpose is to "perform digital radiographic examinations of various anatomic regions on both adult and pediatric patients" and "visualize anatomical structures by converting a pattern of X-ray into a visible image." This is the definition of a medical imaging device, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
MQB, KPR
Device Description
The BladeView is intended to be used as a universal diagnostic imaging system for radiographic studies.
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
skull, spinal column, chest, shoulder girdle, abdomen, pelvic girdle and extremittee.
Indicated Patient Age Range
adult and pediatric patients
Intended User / Care Setting
Qualified operator / Not specified but inferred as clinical setting based on examinations and procedures.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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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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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
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K // ///////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////
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/
,
.
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KI01042
PAGE 4 OF 10
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•
SECTION H
510(K) Summary
.
.
5
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. .
K101042
PAGE 6 OF 10
6
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.' ··
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
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SECTION H
.
510(K) Summary
8
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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
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
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SECTION G
INDICATIONS FOR USE STATEMENT
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