(168 days)
Not Found
No
The description focuses on mechanical components and manual control of the X-ray field. There is no mention of AI, ML, or any form of automated image analysis or decision-making based on data.
No
The device is described as an "X-Ray beam limitation device" and an "X-ray Collimator," which are used in diagnostic imaging to limit the X-ray field size and reduce off-focus radiation. Its function is to assist in accurate imaging, not to provide therapy or treatment.
No
The device is described as an X-ray beam limitation device (collimator) for diagnostic X-ray units, not a diagnostic device itself. Its function is to limit the X-ray field size, not to diagnose conditions.
No
The device description clearly outlines physical components like an external cover, lead shutters, knobs, and a lead cone, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is an "X-Ray beam limitation device on portable and mobile diagnostic X-Ray units." This describes a component used in medical imaging equipment, not a device that performs tests on biological samples (like blood, urine, tissue, etc.) to diagnose conditions.
- Device Description: The description details the physical components and function of an X-ray collimator, which shapes and limits the X-ray beam. This is consistent with an imaging accessory, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, performing chemical or biological reactions, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device operates in vivo (within the body) as part of an X-ray imaging system.
N/A
Intended Use / Indications for Use
Model R72 is intended to be used as an X-Ray beam limitation device on portable and mobile diagnostic X-Ray units.
Product codes (comma separated list FDA assigned to the subject device)
IZX, KPW
Device Description
R72 X-Ray Collimator: External cover in abs plastic
Single-layer, square field radiological collimator.
Focus/mounting flange plane distance is 70mm.
The X-ray field size is limited by two pairs of lead shutters controlled by two knobs located on the sides of the collimator, a lead cone situated near the x-ray anode reduces the off-focus radiation. Its light weight and compact size allow easy positioning and make it ideal for portable units. A table on the front panel allows the operator to read field dimensions set with the knobs.
Specifications
Warning: This collimator is not to be used with rotating anode X-ray tubes.
External adjustment of mirror angulation.
High luminosity provided by a quartz iodide lamp (100W 24V).
Timer limiting projection lamp exposure time to 30 seconds, adjustable, thus
extending lamp life and preventing overheating.
Radiation protection up to 125 kVp 4mA .
Minimum Inherent filtration 2mm aluminum equivalent. (1mm on request)
Continuous film coverage from 0x0 cm to 35x35 cm +/-1% FFD at an FFD of 70cm.
Mentions image processing
Not Found
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
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 and user testing indicates that the new device is as safe and effective as the predicate device.
After analyzing both bench and user testing data, it is the conclusion of Ralco that the Model R72 is as safe and effective as the predicate device, have few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate device.
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.
Ralco Model R302, K946320
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.
Not Found
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
§ 892.1610 Diagnostic x-ray beam-limiting device.
(a)
Identification. A diagnostic x-ray beam-limiting device is a device such as a collimator, a cone, or an aperture intended to restrict the dimensions of a diagnostic x-ray field by limiting the size of the primary x-ray beam.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
AUG - 1 2003
Page 1 of 2
EXHIBIT 2 510(k) Summary of Safety and Effectiveness RALCO srl Via Schiapparelli 27/33 20035 LISSONE (MI) ITALY Tel: +39 039 464905 Fax: +39 039 2456958 E-MAIL: ralco@ralco.it June 10, 2003
Contact: Vincenzo Velardi, President and CEO
- Identification of the Device: 1. Proprietary-Trade Name: Model R72 Manually Operated X-Ray Collimator Classification Name: COLLIMATOR, MANUAL, RADIOGRAPHIC, Product Code IZX Common/Usual Name: Manually Operated X-Ray Collimator.
-
- Equivalent legally marketed devices: Ralco Model R302, K946320
- Indications for Use (intended use): Model R72 is intended to be used as an X-Ray beam 3. limitation device on portable and mobile diagnostic X-Ray units.
-
- Description of the Device: R72 X-Ray Collimator: External cover in abs plastic
Single-layer, square field radiological collimator.
Focus/mounting flange plane distance is 70mm.
The X-ray field size is limited by two pairs of lead shutters controlled by two knobs located on the sides of the collimator, a lead cone situated near the x-ray anode reduces the off-focus radiation. Its light weight and compact size allow easy positioning and make it ideal for portable units. A table on the front panel allows the operator to read field dimensions set with the knobs.
Specifications
Warning: This collimator is not to be used with rotating anode X-ray tubes.
- · External adjustment of mirror angulation.
- · High luminosity provided by a quartz iodide lamp (100W 24V).
- · Timer limiting projection lamp exposure time to 30 seconds, adjustable, thus
- extending lamp life and preventing overheating.
- · Radiation protection up to 125 kVp 4mA .
- · Minimum Inherent filtration 2mm aluminum equivalent. (1mm on request)
- · Continuous film coverage from 0x0 cm to 35x35 cm ±1% FFD at an FFD of 70cm.
-
- Safety and Effectiveness, comparison to predicate device. The results of bench and user testing indicates that the new device is as safe and effective as the predicate device.
1
| Characteristic | Ralco Model R302, K946320 | Ralco Model R72 K030487 |
|---|---|---|
| Intended Use: | As a collimator on Model for operation on stationary units with fixed or rotating anode x-ray tube. Maximum radiation protection 150 kVp. Manual shutter control. Electronic timer for the activation of the light field. Plastic ABS covers | As a collimator on Model for installation on portable and mobile units with fixed anode x-ray tubes. Maximum radiation protection 125 kVp. Two knobs on either side of the unit provide for the manual control of shutters. Electronic timer for the activation of the light-field simulating the x-ray field. |
| Physical characteristics: | ||
| Size | 207mm H x 196mm W x 237mm D. | 123 mm H x 168 mm W x 200 mm D |
| Weight | 9.5 kg | 3.6 kg |
| Energy Source: | 24 V 100w (lamp) | SAME |
| Timer | 30 sec for light field projection lamp | SAME |
| KvP | 150 KvP max | 125 max |
| Standards and Safety characteristics: | ||
| Performance Standard | 21 CFR 1020.30 | SAME |
| Electrical safety: | UL 2601, IEC 60601-1 | SAME |
-
- Substantial Equivalence Chart, Model R72
7. Conclusion
After analyzing both bench and user testing data, it is the conclusion of Ralco that the Model R72 is as safe and effective as the predicate device, have few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate device.
2
Image /page/2/Picture/1 description: The image shows a black and white logo for the Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES" are arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 1 2003
RALCO S.R.L. % Mr. Daniel Kamm, P.E. Regulatory Engineer Kamm & Associates PO Box 7007 DEERFIELD IL 60015
Re: K030487
Trade/Device Name: Model R72 X-Ray Collimator Regulation Number: 21 CFR 892.1610 Regulation Name: Diagnoatic x-ray beam-limiting device Regulatory Class: II Product Code: 90 KPW
Dated: June 10, 2003 Received: June 13, 2003
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. Iisting 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 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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the 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" (21CFR Part 807.97) you may obtain. 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
Page 2
4
j) Indications for Use
·
510(k) Number K030487
Device Name: Model R72 X-Ray Collimator
Indications for Use: Model R72 is intended to be used as an X-Ray beam limitation device on portable and mobile diagnostic X-Ray units.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use OR
Over the Counter Use (Per 21 CFR 801.109)
Carole L. Symons
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number