(70 days)
No
The document describes a digital X-ray system and its components, focusing on image acquisition and digital processing for display and storage. There is no mention of AI or ML technologies being used for image analysis, interpretation, or any other function.
No
The device is used for acquiring diagnostic images, not for treating a condition.
Yes
The device, ThoraScan, is used to acquire chest x-ray images and convert them into digital images for preview and storage. These images are then reviewed by radiologists or pneumologists to enable the diagnosis of medical conditions, which fits the definition of a diagnostic device.
No
The device description explicitly lists multiple hardware components including a camera stand with detector, tube stand, control unit, x-ray tube, collimator, generator, and the OWS (Operators workstation).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The ThoraScan is a digital X-ray system designed to acquire images of the chest directly from the patient. It does not analyze biological specimens.
- Intended Use: The intended use is for "clinical or mass-chest radiography," which involves imaging the patient's chest using X-rays.
- Device Description: The description details the components of an X-ray imaging system (detector, tube stand, control unit, etc.).
The ThoraScan is a medical imaging device, specifically a radiographic system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Clinical or mass-chest radiography
ThoraScan provides the radiologists or pneumologists the ability to acquire chest x-ray images by filmless radiography (digital radiography), based on a Csl/CCD slot scan detector produced by Thomson TE.
The x-ray transmission profile of the chest is converted into an electronic, digital image in real-time. Chest images become available for preview by the x-ray technician on the operator's workstation only seconds after the x-ray exposure.
operator o wonecation one by the tech, digital (DICOM) images can be stored on electronic media, as e.g. CD-ROM, magnetic disk, or be exported to a (DICOM/PACS) network, c.q. clinical review station or to a film printer.
Product codes
90 KPR
Device Description
ThoraScan is a digital X-ray chest camera based on slot-scan technology and is designed to perform radiographic chest examinations. The detector is comprised of CCD's directly coupled to a cesium iodide scintillator. The digital image is sent through a DICOM network. The ThoraScan consists of a camera stand with detector, tube stand, control unit, x-ray tube, collimator, generator and the OWS (Operators workstation).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
Chest
Indicated Patient Age Range
Not Found
Intended User / Care Setting
radiologists or pneumologists, x-ray technician, medical professional
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)
Non-clinical tests: Prototype tests of the detector include a.o. resolution and contrast measurements which are reported in Tab 10 of this application and which show superior results compared to the Digidelca-C.
Clinical tests: PA and lateral radiograms were judged by several radiologist and found the digital images had better image quality than the Digidelca-C
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
510(K) Nucletron [Oldelft ThoraScan] [June 27th, 2001]
SEP 1 9 2001
Image /page/0/Picture/2 description: The image is a black and white graphic. It features a square border, inside of which is a black oval shape. Two white circles are positioned on opposite sides of the oval, partially overlapping it. The overall design is simple and geometric.
K012165/S1
NUCLETRON B.V.
Waardgelder 1 3905 TH Veenendaal 3900 AX Veenendaal P.O.Box 930 The Netherlands Phone +31 318 557133 Fax +31 318 550485
Department of Health and Human Services Center of Device and Radiological Health Office of Device Evaluation Special 510(k) section
ucletron
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION as required by section 807.92(c)
Submitter of 510(k): a.
| Company name: | Nucletron Corporation |
|---|---|
| Registration number: | 1121753 |
| Address: | 7080 Columbia Gateway Drive |
| Columbia, MD 21046-2133 | |
| Phone: | 410-312-4100 |
| Fax: | 410-312-4197 |
| Correspondent: | Lisa Dimmick |
Device Name: b.
| Trade/Proprietary Name: | Oldelft ThoraScan (internally also known as |
|---|---|
| Name: | ThoraScan and Digidelca-T) |
| Common/Usual Name: | Digital Chest X-ray System |
| Classification Name: | Stationary X-ray System (90-KPR) |
| Classification | Class II |
| CFR Citation | 21 CRF 892.1680 Tier 1 submission |
| Panel | Radiology |
Legally Marketed Device(s) C.
Our device is substantially equivalent to the legally marketed predicate device cited in the table below:
| Manufacturer | Device | 510(k) # |
|---|---|---|
| Nucletron BV | Digidelca | K980296 |
Description: ರ.
ThoraScan is a digital X-ray chest camera based on slot-scan technology and is designed to perform radiographic chest examinations. The detector is comprised of CCD's directly coupled to a cesium iodide scintillator. The digital image is sent through a DICOM network. The ThoraScan consists of a camera stand with detector, tube stand, control unit, x-ray tube, collimator, generator and the OWS (Operators workstation).
1
510(K) Nucletron [Oldelft ThoraScan] [June 27th, 2001]
Intended use e.
Clinical or mass-chest radiography
Summary of technological considerations f.
The ThoraScan is substantially equivalent to the predicate device (Digidelca). Compared to the Digidelca the slot-scan detector and the control unit have been improved.
The ThoraScan presents no new safety concerns. It will comply with the x-ray requirements of 21CFR 1020.30/31 as well as safety requirements of UL -187, IEC601-1 rood collateral standards, as well as the requirements of the Medical Device Directive (93/42/EEC) and the EMC Directive (89/336/EEC).
Non-clinical tests ்.
Prototype tests of the detector include a.o. resolution and contrast measurements which are reported in Tab 10 of this application and which show superior results compared to the Digidelca-C.
Clinical tests h.
PA and lateral radiograms were judged by several radiologist and found the digital images had better image quality than the Digidelca-C
Conclusions i.
Nucletron considers the ThoraScan to be equivalent with the predicate device. The ThoraScan provides radiograms that result in better imaging performance than Digidelca.
Jtc
Name: Rudolf Scholte Title: Business Manager Nucletron B.V. Veenendaal, The Netherlands
28/06/01
Date
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a symbol. The symbol consists of three stylized human profiles facing right, with flowing lines above them. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Public Health Service
SEP 1 9 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Lisa Cole Dimmick Director of Regulatory Affairs Nucletron Corporation 7080 Columbia Gateway Drive COLUMBIA MD 21046-2133
Re: K012165
Trade/Device Name: Oldelft Thorascan Number 180T Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary X-Ray System Regulatory Class: II Product Code: 90 KPR Dated: August 24, 2001 Received: August 27, 2001
Dear Ms. Dimmick
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 either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
3
This letter will allow you to begin marketing your device as described in your 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
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
proceed to the market.
4
510(K) Nucletron [Oldelft ThoraScan] [June 27, 2001]
Image /page/4/Picture/1 description: The image shows the word "Nucletron" in bold, black font. To the left of the word is a square logo. The logo contains a black circle with two white circles inside of it.
NUCLETRON B.V. Waardgelder 1 3905 TH Veenendaal 3900 AX Veenendaal P.O.Box 930 The Netherlands Phone +31 318 557133 Fax +31 318 550485
Department of Health and Human Services Center of Device and Radiological Health Office of Device Evaluation Special 510(k) section
Statement of intended use
Device Name:
Oldelft ThoraScan
Intended Use:
ThoraScan provides the radiologists or pneumologists the ability to acquire chest x-ray images by filmless radiography (digital radiography), based on a Csl/CCD slot scan detector produced by Thomson TE.
The x-ray transmission profile of the chest is converted into an electronic, digital image in real-time. Chest images become available for preview by the x-ray technician on the operator's workstation only seconds after the x-ray exposure.
operator o wonecation one by the tech, digital (DICOM) images can be stored on electronic media, as e.g. CD-ROM, magnetic disk, or be exported to a (DICOM/PACS) network, c.q. clinical review station or to a film printer.
Note: PACS, networks, clinical review stations and (laser-) film printers are not considered part of the Digidelca system for which this application is filed, only external interfaces tot this type of equipment are defined.
Prescription use:
The Nucletron Oldelft ThoraScan is intended to be used for medical procedures on patients to be prescribed and performed by a suitably trained and certified medical professional.
ui
Name: Title: Business Manager Nucletron B.V. Veenendaal, The Netherlands
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K012165
28/6/01.
Date
Prescription Use ✓