(115 days)
K1100403, K063781
No
The summary explicitly states "Not Found" for mentions of AI, DNN, or ML, and the device description focuses on combining existing cleared hardware and image processing software without indicating any AI/ML components.
No
The device is described as acquiring digital radiographic images and is part of a radiographic system, which is used for diagnostic imaging, not for treating diseases or conditions.
No
Explanation: The device acquires digital radiographic images but does not provide interpretations or diagnose conditions. It is a tool for imaging, and the interpretation of those images for diagnosis would be done by a qualified medical professional.
No
The device description explicitly states it is a combination of a Wireless Portable Detector (hardware) and image processing software. It details the hardware components of the detector.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for acquiring digital radiographic images as part of a radiographic system. This is a medical imaging function, not a diagnostic test performed on biological samples in vitro (outside the body).
- Device Description: The description details components related to capturing X-ray images (detector, docking station, cables) and processing those images. There is no mention of reagents, assays, or analysis of biological specimens.
- Input Imaging Modality: The input modality is "Radiographic," which is a form of medical imaging using X-rays. IVDs typically use methods like chemical analysis, immunoassay, or molecular diagnostics.
The device is a component of a radiographic system used for medical imaging, which is distinct from in vitro diagnostics.
N/A
Intended Use / Indications for Use
Intended for use by a qualified/trained doctor or technologist. As part of a radiographic system, the KryslalRad 660 intended to acquire digital radiographic images. It is suite for all routine radiography exams, including specialist areas like intensive care, trauma, or pediatric work, candidating fluoroscopy, angiography and manimography,
Product codes (comma separated list FDA assigned to the subject device)
MQB (Note: It is also listed as MOB in another section, but MQB is the initial classification name and the one typically associated with solid state x-ray imagers).
Device Description
This device is simply the conbination of two cleared devices, the same Wireless Portable Detector as used in the FD-W I (K90062) marketed by Philips Medical Systems and the image processing software cleared in our K080522 DDR MAK Series. Alternately the image processing software is the same as in Omil'ision, K. 100403 made by Modern Module Inc. The Wireless Portable Detector consists of three main parts: Portable in radiography detector (x-ray sensitive part); Docking station which is directly connected to the radiographic workshow and a backup cable which can connect the decector to the docking station if the wireless connection cable which can connect the detector to the docking if the wireless connection cannot be used. Detector size: 35 x 43 cm (14 x 17") Image matrix size: 3000 pixels x 2400 pixels. Pixel size 144 um Image matrix size: 3000 pixels x 2400 pixels. Pixel size: 144 µm, 1mage resolution up to 3.5 LP/mm. The device is intended as an upgrade to cxisting film x-ray systems. It should be installed by a qualifics trained by a qualifics trained.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified/trained doctor or technologist
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)
Clinical images were acquired and compared to our predicate images. There no significant differences between them. We also performed integration testing. The results of a review of clinical, between them. We also performed integration testing. The that the new device is as safe and effective as our predicate device. The modified device conforms to US Performance Standards and the hardware is U. Listed to US Standards for safety for medical devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K1100403 (Note: Typo in document, likely K100403), K063781
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
K1.12132
NOV 1 8 2011
510(K) Summary, 510(k) K11 Submitter: MedicaTech USA 50 Maxwell Irvine , CA , 92618 Toll Frce : +1 800 817 5030 Phone : +1 949 679 2881 FAX : +1 949 679 2882 Registration Number 3004989804 Contact: George Makar, Predsident Date Prepared: July 10, 2011
1. I dentification of the Device:
i
Proprietary-Trade Devel.
Proprietary-Trade Name: KrystalRad 660 Digital Radiographic Portable Retrofit System Classification Name: Solid state x-ray imager (flat panel/digital imager), MQB
Common/Usual Name: Solid state x-ray imager (flat panel/digital imager), MQB Common/Usual Name: Digital X-Ray Panel
Equivalent legally marketed devices: 2.
- The image processing software is the same as provided in our 510(k) K080582 DDR MAK . Series. Allemately the image processing sollware is the same as in OmniVision, K. I 100403
made by Modely Module Inc made by Modern Module Inc. - The Detector is identical to the Wireless Portable Detector FD-W17 (K090625) marketed by
Philips Mcdical Systems . Philips Medical Systems - Description of the Device: This device is simply the conbination of two cleared devices, the 3. same Wireless Portable Detector as used in the FD-W I (K90062) marketed by Philips Medical Systems and the image processing software cleared in our K080522 DDR MAK Series. Alternately the image processing software is the same as in Omil'ision, K. 100403 made by Modern Module Inc. The Wireless Portable Detector consists of three main parts: Portable in radiography detector (x-ray sensitive part); Docking station which is directly connected to the radiographic workshow and a backup cable which can connect the decector to the docking station
if the wireless connection cable which can connect the detector to the docking if the wireless connection cannot be used. Detector size: 35 x 43 cm (14 x 17") Image matrix size:
3000 pixels x 2400 pixels. Pixel size 144 um Image matrix size: 3000 pixels x 2400 pixels. Pixel size: 144 µm, 1mage resolution up to 3.5 LP/mm. The device is intended as an upgrade to cxisting film x-ray systems. It should be installed by a qualifics trained by a qualifics trained -
- Indications for Use (intended use): Intended for use by a qualifical/trained doctor or technologist. As part of a radiographic system, the KryslalRad 660 intended to acquire digital radiographic images. It is suite for all routine radiography exams, including specialist areas like intensive care, trauma, or pediatric work, candidating fluoroscopy, angiography and manimography,
- Safety and Effectiveness, comparison to predicate device. This combination device has the પંચ same indications for use and technological characteristics as the prodication devices, in fact employing the predicate devices in the end product.
-
- Description of Testing: Clinical images were acquired and compared to our predicate images. There no significant differences between them. We also performed integration testing. The results of a review of clinical, between them. We also performed integration testing. The that the new device is as safe and effective as our predicate device. The modified device conforms to US Performance Standards and the hardware is U. Listed to US Standards for safety for medical devices.
1
7. Substantial Equivalence Chart
ア・・・・
··············································································································································································
ﺑ
| Characteristic | Philips Wireless Portable Detector
FD-W17 K090625 | KrystalRad 660 |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: | As a part of a radiographic system,
the Wireless Portable Detector FD-
W17 is intended to acquire
digital radiographic images. The
Wireless Portable Detector
FD-W1 7 is suitable for all routine
radiography exams, including
specialist areas like intensive care,
trauma, or pediatric work,
excluding fluoroscopy,
angiography and mammography. | Intended for use by a qualified/trained
doctor or technologist. As part of a
radiographic system, the KrystalRad
660 is intended to acquire digital
radiographic images. It is suitable for
all routine radiography exams,
including specialist areas like intensive
care, trauma, or pediatric work,
excluding fluoroscopy, angiography
and mammography. |
| Configuration | Battery operated wireless | SAME |
| Performance Standard | 21 CFR 1020.30 | SAME |
| Image acquisition panel | PIXIUM PORTABLE 3543 | SAME |
| Image acquisition
software | Philips XD-S workstation
(K063781) | Same as: K080582 DDR MAK Series
Medicatech USA (E-Com) - OR-
K110040 OmniVision, Modern
Module Inc. |
| Communication | WiFi or hardwire | SAME |
| Electrical safety | Electrical Safety per IEC-60601.
UL listed | SAME
SAME |
- Conclusion: After analyzing software integration validation, safety testing data, and clinical images, it is the conclusion of Mcdicatech USA that the KrystalRad 660 is as safe and clinical
the predicate devices, have almost no technological liff the predicate devices, have almost no technological differences, and has identical indications for use, thus rendering it substantially equivalent to the predicate devices,
2
Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo includes the department's emblem on the left, which features a stylized human figure. To the right of the emblem, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is displayed in a clear, sans-serif font.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Medica Tech USA % Mr. Daniel Kamm, P.E. AUG 2 3 2013 Regulatory Engineer, Submission Correspondent Kamm & Associates 8870 Ravello Court NAPLES FL 34114
Re: K112132
Trade/Device Name: KrystalRad 660 Digital Radiographic Portable Retrofit System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: October 17, 2011 Received: October 20, 2011
Dear Mr. Kamm:
This letter corrects our substantially equivalent letter of November 18, 2011.
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
3
medical device-related adverse events) (21 CFR 803); and good manufacturing practice modious 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 witification. The FDA finding of substantial equivalence of your device to a legally marketed nodicate 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 If you desire specific advice of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-000), 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 under the MDA regulation (21 °CF (1 at 009), processor of 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 Tou inay 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
4
Indications for Use
510(k) Number (if known): K112| 32
Device Name: KrystalRad 660 Digital Radiographic Portable Retrofit System
Indications For Use:
Intended for use by a qualified/trained doctor or technologist. As part of a radiographic system, the KrystalRad 660 is intended to acquire digital radiographic images. It is suitable for all routine radiography exams, including specialist areas like intensive care, trauma, or pediatric work, excluding fluoroscopy, angiography and mammography.
Prescription Usc _ X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 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)
(Division Sign-Off)
Division of Radiological Dou
Office of in Vitro O
Office of In Vitro Radiological Devices
Diagnostic Device Evaluation and
510K B112132
Page 1 of 1
Page 17 of 1256
- ***** : ***
· (