(27 days)
No
The summary does not mention AI, ML, deep learning, or any related terms, nor does it describe features or performance metrics typically associated with AI/ML-powered devices.
No
The device is used for generating radiographic images for diagnostic procedures, not for treatment.
Yes
The "Intended Use / Indications for Use" states that the systems are intended for "all general-purpose diagnostic procedures."
No
The device description explicitly states it is an "X-Ray System" and "Solid State X-ray Imaging systems," indicating it includes hardware components for generating and capturing X-ray images.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "generating radiographic images of human anatomy" and "replace radiographic film/screen systems in all general-purpose diagnostic procedures." This describes an imaging device used to visualize internal structures of the body.
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description mentions producing "digital x-ray images," which aligns with an imaging device, not a device that analyzes biological samples.
- Input Imaging Modality: The input modality is "X-ray," which is an imaging technique, not a method for analyzing biological samples.
The information provided consistently points to a medical imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
PanoRad and PanoRad SL X-Ray Systems are indicated for use in generating radiographic images of human anatomy. It has a Solid State X-ray Imaging system intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures. Not for mammography.
Product codes (comma separated list FDA assigned to the subject device)
KPR, MQB, LLZ
Device Description
The modified device can produce digital x-ray images in various configurations.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
human anatomy
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
The results of bench, clinical, and standards testing indicates that the modified device is as safe and effective as the predicate devices. The changed components are in fact identical to the predicate 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.
K111583, K080064, K102349, K070618, K091364, K073114
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
ﻟﻠﻤﺨﺘﻠﻔﺔ
JAN 2 5 2012
510(k) Summary K113855
IMIX ADR Finland OY Peltokatu 16 D3 33100 Tampere, Finland Telephone: +358 (3) 2129 850 Fax: +358 (3) 2129 852 E-mail: emea@imixadr.com Contact: Peter Reinli President Date Prepared: November 11, 2011
-
- Identification of the Device: Proprietary-Trade Name: PanoRad and PanoRad SL Systems Classification Name: Stationary X-ray system, Product Codes Product Codes KPR, MQB, and LLZ Common/Usual Name: General purpose diagnostic X-ray Units with Digital X-ray receptor panels.
-
- Indications for Use (intended use) PanoRad and PanoRad SL X-Ray Systems are indicated for use in generating radiographic images of human anatomy. It has a Solid State X-ray Imaging system intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures. Not for mammography.
-
- Description of the Device: The modified device can produce digital x-ray images in various configurations.
| Product
Name | Mechanics | Generator | Detector | Workstation
Software |
|-----------------|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| PanoRad | ShinYoung for M Co.
SU-1001 | CPI
CMP 200 or CMP
200DR
50 or 65 kW
-OR-
Stadler Elektronik
8x Series
50 or 65 kW
-OR-
EMD Technologies
EPS 45-80 Rad
FOR ALL MODELS | IMIX ADR OY
IMIX 2000 UNV3K or 4K
-OR-
DRTech FLAATZ 560
(K111583) or
FLAATZ 750E (K080064)
-OR-
AERO DR
(K102349 KONICA
MINOLTA) | Oehm und
Rehbein
dicomPACS
(K070618) An
Image Acquisition
workstation with
DICOM 3
compliance
FOR ALL
DETECTORS
(except Aero DR) |
| PanoRad
SL | ShinYoung for M Co.
SU-1001 or SU-3001 | | | |
Here is a product configuration matrix:
-
- Safety and Effectiveness, comparison to predicate device. The results of bench, clinical, and standards testing indicates that the modified device is as safe and effective as the predicate devices. The changed components are in fact identical to the predicate devices.
1
6. Substantial Equivalence Chart, PanoRad and PanoRad SL Systems
| Characteristic | IMIX PanoRad and SomaRad X-Ray Systems, K101435 | PanoRad or PanoRad SL X-Ray Systems, Modified device |
|---|---|---|
| Intended Use: | Indicated for use in generating | |
| radiographic images of human | ||
| anatomy. It has a Solid State X-ray | ||
| Imaging system intended to replace | ||
| radiographic film/screen systems in all | ||
| general-purpose diagnostic procedures. | ||
| Not for mammography | SAME | |
| User Interface | Software Driven Touch Panel LCD | Software Driven Touch Panel LCD |
| Generator | CPI or Stadler | CPI, Stadler, or EMD Technologies |
| Maximum output | 50 and 65 kW | 45, 50, 65 or 80 kW |
| Stand | Supplied by Shinyoung For M Co Ltd | Supplied by Shinyoung For M Co Ltd |
| Image Acquisition | IMIX or Varian Digital Radiographic | |
| Detectors | IMIX ADR OY | |
| IMIX 2000 UNV3K or 4K | ||
| -OR- | ||
| DRTech FLAATZ 560 (K111583) | ||
| or FLAATZ 750E (K080064) | ||
| -OR- | ||
| AERO DR | ||
| (K102349) | ||
| Digital Panel Size | 14" x 17" (4336R) | |
| 17" x 17: (4343R) | ||
| 16" x 16" | Added panels: | |
| FLAATZ 750E 14 x 14 | ||
| FLAATZ 560 14 x 17 | ||
| AERO DR: 14 x 14 or 14 x 17 | ||
| Digital Panel Supplier | IMIX panels, same as in K073114 OR: | |
| Varian 4343R or 4336R | IMIX panels, DRTech, or Konica | |
| Minolta | ||
| Digital Resolution | 7.9 megapixel or 9.4 megapixel. 139 μ | FLAATZ 750E: 6.6 megapixel 168 μ |
| FLAATZ 560 7.9 megapixel 139 μ | ||
| AERO DR: 5 megapixel 175μ | ||
| DICOM | Yes, via O&R software cleared in | |
| K091364 | Yes, via O&R software cleared in | |
| K091364 | ||
| Method of Control | Touch Panel LCD | Touch Panel LCD |
| Collimator | Ralco R302L/A DHHS | Ralco R302L/A DHHS |
| Safety | UL listed | UL listed |
- Conclusion: After analyzing bench, clinical, and standards testing data, it is the conclusion of IMIX ADR that the IMIX PanoRad and PanoRad SL X-Ray Systems are as safe and effective as the predicate devices, have few technological differences, and have no new indications for use, thus rendering them 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 - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an eagle or bird in flight, composed of three curved lines.
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
IMIX ADR Finland OY % Mr. Daniel Kamm, P.E. Regulatory Engineer Kamm & Associates 8870 Ravello Court NAPLES FL 34114
JAN- 2 5-2012 .
Re: K113855
Trade/Device Name: PanoRad, PanoRad SL X-Ray Systems Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR, MQB, LLZ Dated: December 20, 2011 Received: December 29, 2011
Dear Mr. Kamm:
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 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,
Mary Pastel
Mary S. Pastel, Sc.D. 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):K11 30
Device Name: PanoRad, PanoRad SL X-Ray Systems
Indications For Use:
IMIX PanoRad and PanoRad SL X-Ray Systems are indicated for use in generating radiographic images of human anatomy. They have Solid State X-ray Imaging systems intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures. (Not for mammography.)
Prescription Use 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)
Page 1 of 1
Mary Spatel
Division of Radiological Devic Office of In Vit 510K